GliomaVASIMNCT05274919
Vascular Signature Mapping of Brain Tumor Genotypes
An observational study of Glioma, run by Leiden University Medical Center at 2 sites in Netherlands.
Trial summary
A glioma is a primary brain tumor in adults that is characterized by a highly variable, but overall poor survival. The optimal timing of treatment is in part determined by the expected biological behavior of the tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- Philips Achieva 7T MRI, X-ray (optional) and Additional contrast injection
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 180 participants
- Where
- 2 sitesNetherlands
- Study dates
- 16 Aug 2022to 31 Mar 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The first cohort, for protocol development and optimization, consists of 60 patients scheduled for brain MRI as part of their standard clinical diagnostic procedure and in whom contrast administration is part of their standard radiological assessment. These patients do not necessarily have a brain tumor as the purpose is to develop and evaluate the vascular signature mapping sequence in general. The second cohort consists of 20 glioma patients in whom the vascular signature mapping sequence is tested and for a direct comparison between 3T and 7T MRI, where the 3T scan is an extension of the diagnostic care and the additional 7T scan is optional. The third cohort, for the clinical proof-of-concept study, consists of 100 adult patients referred for biopsy or surgery of suspected glioma.
Who may be able to join
- Patients scheduled for brain MRI with contrast injection as part of the clinical diagnostic procedure (cohort 1)
- Patients diagnosed with suspected glioma scheduled for brain MRI as part of the clinical diagnostic procedure (cohort 2)
- Patients with (suspected) glioma referred for tumor biopsy or resection (cohort 3)
- Age ≥ 18 years (all cohorts)
- Signed informed consent (all cohorts)
Who cannot join
- Subjects with contra-indications for an MRI exam
- Subjects with reduced kidney function because of the risk on developing nephrogenic systemic fibrosis (NSF) under gadolinium-based contrast injection
- Subjects with pregnancy
- Subjects undergoing a clinical protocol that requires scanning during CA injection (cohort 1)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Matthias JP van Osch, Prof Dr Ir contact
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Leiden University Medical Center
Leiden, 2333ZA
Daniëlle van Dorth, MSc, +31657056608, d.van_dorth@lumc.nl
Matthias van Osch, Professor, m.j.p.van_osch@lumc.nl
- Recruiting
Erasmus University Medical Center
Rotterdam, 3000CA
Krishnapriya Venugopal, MSc, k.venugopal@erasmusmc.nl
Marion Smits, Professor, marion.smits@erasmusmc.nl
About this study
A glioma is a primary brain tumor in adults that is characterized by a highly variable, but overall poor survival. The optimal timing of treatment is in part determined by the expected biological behavior of the tumor. At present the expected biological behavior, determined by the tumor genotype, can only be determined by tissue analysis, which requires brain surgery. Non-invasive and improved diagnostic methods are sought to obtain insight into the molecular profile of the tumor and the expected biological behavior to avoid surgery performed solely for diagnostic purposes. Vascularization is an important aspect of the biological behavior of a primary brain tumor. Tumor vascularization characteristics can be assessed by Magnetic Resonance Imaging (MRI), but with the currently available technology this can only be achieved with unacceptably long scan times. In this proposal, the investigators will develop and optimize a novel MRI protocol to gather a large set of quantitative vascularization parameters within an acceptable scan time. The hypothesis is that from such a 'vascular signature' the tumor genotype can be inferred by means of machine learning.
Read the detailed description
Objective of the study:
The primary objective is to develop and clinically validate a fast multi-parametric MRI acquisition technique, for non-invasive and comprehensive characterization of the tumor's vascularization, 'vascular signature mapping', at 3 Tesla (3T) and 7 Tesla (7T) MRI.
The secondary objective is to limit difficult and time-consuming visual interpretation of the acquired vascular information by developing a computer-aided diagnostic algorithm that automatically and accurately predicts the brain tumor genotype from the vascular signature maps.
Study design:
The study 'Vascular Signature Mapping for Brain Tumor Genotypes' is a multi-center observational diagnostic study, which consists of two parts. The first part of this study aims to develop and optimize a new MRI protocol that will exploit the effect of contrast agent on the MRI signal to infer information on the vascular properties of a tumor. It combines scans during the pre-contrast injection phase, the dynamic phase during and right after contrast agent injection, as well as the quasi static post-contrast phase. This research will focus on studying the optimal way of encoding the vascular architecture into the MRI signal and the decoding approach, In addition, the image processing methodology will be optimized. The second part of this study is a proof-of-concept clinical study. This part aims to link the vascular parameters with molecular profiles of tumors by using the collected data for the development of machine learning algorithms for predicting the tumor's genotype based on its vascular signature.
Study population:
The study population consists of 3 cohorts, all aged over 18 years, able to provide written informed consent and without contraindications for contrast-enhanced MRI. The first cohort, for development and optimization of the protocol, consists of 60 patients scheduled for brain MRI as part of their standard clinical diagnostic procedure and in whom contrast agent (CA) administration is part of their standard radiological assessment. These patients do not necessarily have a brain tumor as the purpose here is to develop and evaluate the vascular signature mapping sequence in general. The second cohort consists of 20 glioma patients in whom the vascular signature mapping sequence is tested and for a direct comparison between 3T and 7T MRI, where the 3T scan is an extension of the diagnostic care and the additional 7T scan is optional. The third cohort, for the clinical proof-of-concept study, consists of 100 adult patients referred for biopsy or surgery of suspected glioma.
Primary study parameters/outcome of the study:
The endpoint of the first part of the study is a novel MRI protocol for characterization of the vessel architecture, assessed with respect to the signal-to-noise ratio (SNR) and the ability to obtain vascular Information. The main parameters that will be used for characterization of the vasculature are physiological parameters including the vessel architecture, cerebral blood volume (CBV), cerebral blood flow (CBF), mean transit time (MTT), and oxygenation level.
The main study end point of the second part of the study is the accuracy of automatic classification of the tumor's genotype. The accuracy of the new method will be compared to the current state-of-the-art reference method based on conventional MRI.
Secondary study parameters/outcome of the study:
Baseline characteristics of subjects (including age, sex, Karnofsky performance status, tumor histology, molecular parameters (1p/19q, Isocitrate Dehydrogenase (IDH1/2) and 06-Methylguanine-DNA Methyltransferase (MGMT) status), tumor location, supportive and antitumor treatment). In addition, the outcome (e.g. mortality, tumor progression, radiation necrosis, functioning of patients) will be used as study parameter. The outcome will be determined from the follow-up scans after 3 and 6 months, where the criterion for progression or pseudo-progression is determined by the outcome of the scan.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
For the first cohort, the additional burden will not be substantial for the participant. The additional scan time will not exceed 10 minutes and therefore the impact on the patient will be limited. For the second and third cohort, the additional burden includes a prolonged MRI examination at a clinical MRI scanner (3T) and an optional additional examination at 7T MRI including additional CA injection. The ultrahigh field 7T MRI system is commonly used for research and no serious adverse events have been reported. Patients participating in this study will have no personal benefit; their participation aids in the development of a novel MRI method for the non-invasive determination of the tumor's molecular profile. Moreover, there is a small chance that the additional 7T MRI scan would provide more Information on the status of the disease in the participant.
- Conditions
- Glioma
- Being tested
- Philips Achieva 7T MRI, X-ray (optional), Additional contrast injection, Question list
- Keywords
- MR imaging
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philips Achieva 7T MRIDevice
Also called Philips Ingenia (Elition) 3T MRI, GE Healthcare (MR750/Signa Premier) 3T MRI
Regular follow-up MRI on 3T scanner and optional additional scan at 7T MRI.
X-ray (optional)Device
Optional X-ray scan to assess the safety for undergoing an MR examination.
Additional contrast injectionCombination product
Contrast agent administration for the additional 7T scan (optional).
Question listOther
Questionnaire for contra-indications for an MR examination.
| Study group | Role | What they receive |
|---|---|---|
| Patients scheduled for brain MRI with contrast injection | Inclusion at Erasmus MC and LUMC: The first cohort consists of 60 patients scheduled for brain MRI as part of their standard clinical diagnostic procedure and in whom contrast agent administration is part of their standard radiological assessment. These patients do not necessarily have a brain tumor as the purpose here is to develop and evaluate the vascular signature mapping sequence in general. Usually, such testing would be done in healthy volunteers, but contrast agent is required for the vascular signature mapping sequence. To avoid unnecessary contrast agent administration, the sequence will be tested in this patient cohort instead. In this study part, the outcome is the optimized protocol itself, with which the investigators could obtain additional information about the vascular structure throughout the brain. Therefore this group of subjects is expected to be sufficiently homogeneous for the research aim of this part of the study. Receives: Device: X-ray (optional); Other: Question list | |
| Patients diagnosed with suspected glioma scheduled for brain MRI | Inclusion at Erasmus MC and LUMC: The second cohort consists of 20 glioma patients in whom the vascular signature mapping sequence is tested specifically for glioma and for a direct comparison between 3T and 7T, where the 3T scan is an extension of the diagnostic care and the additional 7T scan is optional. This number of patients is sufficient to provide information on differences in the ability to measure tumor vascularity between 3T and 7T, while minimizing the extra patient burden. Receives: Device: Philips Achieva 7T MRI; Device: X-ray (optional); Combination Product: Additional contrast injection; Other: Question list | |
| Patients with (suspected) glioma | Inclusion at Erasmus MC and LUMC: The third cohort consists of 100 adult patients referred for biopsy or surgery of suspected glioma. The diagnosis of glioma is based on a multitude of factors, such as initial presentation (headaches, vomiting, potential changes in character). Based on the initial presentation a patient may be suspected of having a glioma, which is often confirmed using imaging. Although a true conclusion requires analysis of tissue, in an overwhelming majority of the cases (99%), analysis of the imaging is sufficient to confirm the presence of glioma. Thus, the investigators can be relatively certain about the inclusion of glioma patients based on the initial presentation and imaging alone.
Since there is a close collaboration with the Neurology departments of both the LUMC and Haaglanden Medical Center (HMC) in The Hague, the investigators broaden their inclusion capacity also to this hospital. Receives: Device: Philips Achieva 7T MRI; Device: X-ray (optional); Combination Product: Additional contrast injection; Other: Question list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimized MR protocol
MR protocol optimized for SNR and the ability to obtain vascular information
Measured: 6 months
Vessel architecture
Structure of vessels and tortuosity
Measured: 4 years
Cerebral blood volume
To characterize the tumor's vasculature
Measured: 4 years
Cerebral blood flow
To characterize the tumor's vasculature
Measured: 4 years
Transit time parameters
Timing parameters used to characterize the tumor vasculature
Measured: 4 years
Vascular oxygenation level
Oxygen-related parameters that describe the tumor's vasculature
Measured: 4 years
Secondary outcomes (8)
Basic subject characteristics
Age, gender, KPS performance score
Measured: 4 years
Tumor histology
Structural information about the tumor, cell type and architectural pattern
Measured: 4 years
Tumor molecular parameters
IDH mutation, MGMT status
Measured: 4 years
Treatment information
Radiotherapy dose, chemotherapy scheme
Measured: 4 years
Tumor progression scored on follow-up MR scan
Assessment of tumor progression versus pseudo-progression based on scoring of follow-up MR scans by an experienced physician.
Measured: 4 years
Radiation necrosis evaluated on follow-up MR scan
Assessment based on evaluation of follow-up MR scans by an experienced physician.
Measured: 4 years
Mortality
Survival time and occurrence of death
Measured: 4 years
KPS score at follow-up of 3 and 6 months
Performance score providing information about the functioning of patients
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start16 Aug 2022
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Responsible party
- Principal investigator, Matthias van Osch, Leiden University Medical Center
- Investigators
- Matthias JP van Osch, Prof Dr Ir, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274919
- Sponsor's protocol ID
- VSMBTG
- Acronym
- VASIM
- Status last verified
- Mar 2025
- First submitted
- 8 Feb 2022
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Smits M, van den Bent MJ. Imaging Correlates of Adult Glioma Genotypes. Radiology. 2017 Aug;284(2):316-331. doi: 10.1148/radiol.2017151930.
PubMed 28723281van den Bent MJ, Smits M, Kros JM, Chang SM. Diffuse Infiltrating Oligodendroglioma and Astrocytoma. J Clin Oncol. 2017 Jul 20;35(21):2394-2401. doi: 10.1200/JCO.2017.72.6737. Epub 2017 Jun 22.
PubMed 28640702Louis DN, Perry A, Reifenberger G, von Deimling A, Figarella-Branger D, Cavenee WK, Ohgaki H, Wiestler OD, Kleihues P, Ellison DW. The 2016 World Health Organization Classification of Tumors of the Central Nervous System: a summary. Acta Neuropathol. 2016 Jun;131(6):803-20. doi: 10.1007/s00401-016-1545-1. Epub 2016 May 9.
PubMed 27157931Fischer I, Gagner JP, Law M, Newcomb EW, Zagzag D. Angiogenesis in gliomas: biology and molecular pathophysiology. Brain Pathol. 2005 Oct;15(4):297-310. doi: 10.1111/j.1750-3639.2005.tb00115.x.
PubMed 16389942Koeller KK, Rushing EJ. From the archives of the AFIP: Oligodendroglioma and its variants: radiologic-pathologic correlation. Radiographics. 2005 Nov-Dec;25(6):1669-88. doi: 10.1148/rg.256055137.
PubMed 16284142Killela PJ, Pirozzi CJ, Healy P, Reitman ZJ, Lipp E, Rasheed BA, Yang R, Diplas BH, Wang Z, Greer PK, Zhu H, Wang CY, Carpenter AB, Friedman H, Friedman AH, Keir ST, He J, He Y, McLendon RE, Herndon JE 2nd, Yan H, Bigner DD. Mutations in IDH1, IDH2, and in the TERT promoter define clinically distinct subgroups of adult malignant gliomas. Oncotarget. 2014 Mar 30;5(6):1515-25. doi: 10.18632/oncotarget.1765.
PubMed 24722048Holash J, Maisonpierre PC, Compton D, Boland P, Alexander CR, Zagzag D, Yancopoulos GD, Wiegand SJ. Vessel cooption, regression, and growth in tumors mediated by angiopoietins and VEGF. Science. 1999 Jun 18;284(5422):1994-8. doi: 10.1126/science.284.5422.1994.
PubMed 10373119Law M, Young RJ, Babb JS, Peccerelli N, Chheang S, Gruber ML, Miller DC, Golfinos JG, Zagzag D, Johnson G. Gliomas: predicting time to progression or survival with cerebral blood volume measurements at dynamic susceptibility-weighted contrast-enhanced perfusion MR imaging. Radiology. 2008 May;247(2):490-8. doi: 10.1148/radiol.2472070898. Epub 2008 Mar 18.
PubMed 18349315Caseiras GB, Chheang S, Babb J, Rees JH, Pecerrelli N, Tozer DJ, Benton C, Zagzag D, Johnson G, Waldman AD, Jager HR, Law M. Relative cerebral blood volume measurements of low-grade gliomas predict patient outcome in a multi-institution setting. Eur J Radiol. 2010 Feb;73(2):215-20. doi: 10.1016/j.ejrad.2008.11.005. Epub 2009 Feb 6.
PubMed 19201123Grobner T. Gadolinium--a specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis? Nephrol Dial Transplant. 2006 Apr;21(4):1104-8. doi: 10.1093/ndt/gfk062. Epub 2006 Jan 23. No abstract available.
PubMed 16431890van der Voort SR, Incekara F, Wijnenga MMJ, Kapas G, Gardeniers M, Schouten JW, Starmans MPA, Nandoe Tewarie R, Lycklama GJ, French PJ, Dubbink HJ, van den Bent MJ, Vincent AJPE, Niessen WJ, Klein S, Smits M. Predicting the 1p/19q Codeletion Status of Presumed Low-Grade Glioma with an Externally Validated Machine Learning Algorithm. Clin Cancer Res. 2019 Dec 15;25(24):7455-7462. doi: 10.1158/1078-0432.CCR-19-1127. Epub 2019 Sep 23.
PubMed 31548344
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Signature Mapping of Brain Tumor Genotypes
- ClinicalTrials.gov ID
- NCT05274919
- Acronym / sponsor ID
- VASIM / VSMBTG
- Conditions
- Glioma
- Keywords
- MR imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A glioma is a primary brain tumor in adults that is characterized by a highly variable, but overall poor survival. The optimal timing of treatment is in part determined by the expected biological behavior of the tumor. At present the expected biological behavior, determined by the tumor genotype, can only be determined by tissue analysis, which requires brain surgery. Non-invasive and improved diagnostic methods are sought to obtain insight into the molecular profile of the tumor and the expected biological behavior to avoid surgery performed solely for diagnostic purposes. Vascularization is an important aspect of the biological behavior of a primary brain tumor. Tumor vascularization characteristics can be assessed by Magnetic Resonance Imaging (MRI), but with the currently available technology this can only be achieved with unacceptably long scan times. In this proposal, the investigators will develop and optimize a novel MRI protocol to gather a large set of quantitative vascularization parameters within an acceptable scan time. The hypothesis is that from such a 'vascular signature' the tumor genotype can be inferred by means of machine learning.
Detailed description
Objective of the study:
The primary objective is to develop and clinically validate a fast multi-parametric MRI acquisition technique, for non-invasive and comprehensive characterization of the tumor's vascularization, 'vascular signature mapping', at 3 Tesla (3T) and 7 Tesla (7T) MRI.
The secondary objective is to limit difficult and time-consuming visual interpretation of the acquired vascular information by developing a computer-aided diagnostic algorithm that automatically and accurately predicts the brain tumor genotype from the vascular signature maps.
Study design:
The study 'Vascular Signature Mapping for Brain Tumor Genotypes' is a multi-center observational diagnostic study, which consists of two parts. The first part of this study aims to develop and optimize a new MRI protocol that will exploit the effect of contrast agent on the MRI signal to infer information on the vascular properties of a tumor. It combines scans during the pre-contrast injection phase, the dynamic phase during and right after contrast agent injection, as well as the quasi static post-contrast phase. This research will focus on studying the optimal way of encoding the vascular architecture into the MRI signal and the decoding approach, In addition, the image processing methodology will be optimized. The second part of this study is a proof-of-concept clinical study. This part aims to link the vascular parameters with molecular profiles of tumors by using the collected data for the development of machine learning algorithms for predicting the tumor's genotype based on its vascular signature.
Study population:
The study population consists of 3 cohorts, all aged over 18 years, able to provide written informed consent and without contraindications for contrast-enhanced MRI. The first cohort, for development and optimization of the protocol, consists of 60 patients scheduled for brain MRI as part of their standard clinical diagnostic procedure and in whom contrast agent (CA) administration is part of their standard radiological assessment. These patients do not necessarily have a brain tumor as the purpose here is to develop and evaluate the vascular signature mapping sequence in general. The second cohort consists of 20 glioma patients in whom the vascular signature mapping sequence is tested and for a direct comparison between 3T and 7T MRI, where the 3T scan is an extension of the diagnostic care and the additional 7T scan is optional. The third cohort, for the clinical proof-of-concept study, consists of 100 adult patients referred for biopsy or surgery of suspected glioma.
Primary study parameters/outcome of the study:
The endpoint of the first part of the study is a novel MRI protocol for characterization of the vessel architecture, assessed with respect to the signal-to-noise ratio (SNR) and the ability to obtain vascular Information. The main parameters that will be used for characterization of the vasculature are physiological parameters including the vessel architecture, cerebral blood volume (CBV), cerebral blood flow (CBF), mean transit time (MTT), and oxygenation level.
The main study end point of the second part of the study is the accuracy of automatic classification of the tumor's genotype. The accuracy of the new method will be compared to the current state-of-the-art reference method based on conventional MRI.
Secondary study parameters/outcome of the study:
Baseline characteristics of subjects (including age, sex, Karnofsky performance status, tumor histology, molecular parameters (1p/19q, Isocitrate Dehydrogenase (IDH1/2) and 06-Methylguanine-DNA Methyltransferase (MGMT) status), tumor location, supportive and antitumor treatment). In addition, the outcome (e.g. mortality, tumor progression, radiation necrosis, functioning of patients) will be used as study parameter. The outcome will be determined from the follow-up scans after 3 and 6 months, where the criterion for progression or pseudo-progression is determined by the outcome of the scan.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
For the first cohort, the additional burden will not be substantial for the participant. The additional scan time will not exceed 10 minutes and therefore the impact on the patient will be limited. For the second and third cohort, the additional burden includes a prolonged MRI examination at a clinical MRI scanner (3T) and an optional additional examination at 7T MRI including additional CA injection. The ultrahigh field 7T MRI system is commonly used for research and no serious adverse events have been reported. Patients participating in this study will have no personal benefit; their participation aids in the development of a novel MRI method for the non-invasive determination of the tumor's molecular profile. Moreover, there is a small chance that the additional 7T MRI scan would provide more Information on the status of the disease in the participant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients scheduled for brain MRI with contrast injection | – | Device: X-ray (optional), Other: Question listInclusion at Erasmus MC and LUMC: The first cohort consists of 60 patients scheduled for brain MRI as part of their standard clinical diagnostic procedure and in whom contrast agent administration is part of their standard radiological assessment. These patients do not necessarily have a brain tumor as the purpose here is to develop and evaluate the vascular signature mapping sequence in general. Usually, such testing would be done in healthy volunteers, but contrast agent is required for the vascular signature mapping sequence. To avoid unnecessary contrast agent administration, the sequence will be tested in this patient cohort instead. In this study part, the outcome is the optimized protocol itself, with which the investigators could obtain additional information about the vascular structure throughout the brain. Therefore this group of subjects is expected to be sufficiently homogeneous for the research aim of this part of the study. |
| Patients diagnosed with suspected glioma scheduled for brain MRI | – | Device: Philips Achieva 7T MRI, Device: X-ray (optional), Combination Product: Additional contrast injection, Other: Question listInclusion at Erasmus MC and LUMC: The second cohort consists of 20 glioma patients in whom the vascular signature mapping sequence is tested specifically for glioma and for a direct comparison between 3T and 7T, where the 3T scan is an extension of the diagnostic care and the additional 7T scan is optional. This number of patients is sufficient to provide information on differences in the ability to measure tumor vascularity between 3T and 7T, while minimizing the extra patient burden. |
| Patients with (suspected) glioma | – | Device: Philips Achieva 7T MRI, Device: X-ray (optional), Combination Product: Additional contrast injection, Other: Question listInclusion at Erasmus MC and LUMC: The third cohort consists of 100 adult patients referred for biopsy or surgery of suspected glioma. The diagnosis of glioma is based on a multitude of factors, such as initial presentation (headaches, vomiting, potential changes in character). Based on the initial presentation a patient may be suspected of having a glioma, which is often confirmed using imaging. Although a true conclusion requires analysis of tissue, in an overwhelming majority of the cases (99%), analysis of the imaging is sufficient to confirm the presence of glioma. Thus, the investigators can be relatively certain about the inclusion of glioma patients based on the initial presentation and imaging alone. Since there is a close collaboration with the Neurology departments of both the LUMC and Haaglanden Medical Center (HMC) in The Hague, the investigators broaden their inclusion capacity also to this hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The first cohort, for protocol development and optimization, consists of 60 patients scheduled for brain MRI as part of their standard clinical diagnostic procedure and in whom contrast administration is part of their standard radiological assessment. These patients do not necessarily have a brain tumor as the purpose is to develop and evaluate the vascular signature mapping sequence in general. The second cohort consists of 20 glioma patients in whom the vascular signature mapping sequence is tested and for a direct comparison between 3T and 7T MRI, where the 3T scan is an extension of the diagnostic care and the additional 7T scan is optional. The third cohort, for the clinical proof-of-concept study, consists of 100 adult patients referred for biopsy or surgery of suspected glioma.
Key inclusion criteria (5 listed)
- Patients scheduled for brain MRI with contrast injection as part of the clinical diagnostic procedure (cohort 1)
- Patients diagnosed with suspected glioma scheduled for brain MRI as part of the clinical diagnostic procedure (cohort 2)
- Patients with (suspected) glioma referred for tumor biopsy or resection (cohort 3)
- Age ≥ 18 years (all cohorts)
- Signed informed consent (all cohorts)
Key exclusion criteria (4 listed)
- Subjects with contra-indications for an MRI exam
- Subjects with reduced kidney function because of the risk on developing nephrogenic systemic fibrosis (NSF) under gadolinium-based contrast injection
- Subjects with pregnancy
- Subjects undergoing a clinical protocol that requires scanning during CA injection (cohort 1)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Philips Achieva 7T MRIAlso: Philips Ingenia (Elition) 3T MRI, GE Healthcare (MR750/Signa Premier) 3T MRIRegular follow-up MRI on 3T scanner and optional additional scan at 7T MRI. | Device | Patients diagnosed with suspected glioma scheduled for brain MRI, Patients with (suspected) glioma |
| X-ray (optional)Optional X-ray scan to assess the safety for undergoing an MR examination. | Device | Patients diagnosed with suspected glioma scheduled for brain MRI, Patients scheduled for brain MRI with contrast injection, Patients with (suspected) glioma |
| Additional contrast injectionContrast agent administration for the additional 7T scan (optional). | Combination product | Patients diagnosed with suspected glioma scheduled for brain MRI, Patients with (suspected) glioma |
| Question listQuestionnaire for contra-indications for an MR examination. | Other | Patients diagnosed with suspected glioma scheduled for brain MRI, Patients scheduled for brain MRI with contrast injection, Patients with (suspected) glioma |
Primary outcome
Optimized MR protocol
Time frame: 6 months
MR protocol optimized for SNR and the ability to obtain vascular information
Vessel architecture
Time frame: 4 years
Structure of vessels and tortuosity
Cerebral blood volume
Time frame: 4 years
To characterize the tumor's vasculature
Cerebral blood flow
Time frame: 4 years
To characterize the tumor's vasculature
Transit time parameters
Time frame: 4 years
Timing parameters used to characterize the tumor vasculature
Vascular oxygenation level
Time frame: 4 years
Oxygen-related parameters that describe the tumor's vasculature
8 secondary outcomes
Basic subject characteristics
Time frame: 4 years
Tumor histology
Time frame: 4 years
Tumor molecular parameters
Time frame: 4 years
Treatment information
Time frame: 4 years
Tumor progression scored on follow-up MR scan
Time frame: 4 years
Radiation necrosis evaluated on follow-up MR scan
Time frame: 4 years
Mortality
Time frame: 4 years
KPS score at follow-up of 3 and 6 months
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Background: PubMed 28723281Smits M, van den Bent MJ. Imaging Correlates of Adult Glioma Genotypes. Radiology. 2017 Aug;284(2):316-331. doi: 10.1148/radiol.2017151930.
- Background: PubMed 28640702van den Bent MJ, Smits M, Kros JM, Chang SM. Diffuse Infiltrating Oligodendroglioma and Astrocytoma. J Clin Oncol. 2017 Jul 20;35(21):2394-2401. doi: 10.1200/JCO.2017.72.6737. Epub 2017 Jun 22.
- Background: PubMed 27157931Louis DN, Perry A, Reifenberger G, von Deimling A, Figarella-Branger D, Cavenee WK, Ohgaki H, Wiestler OD, Kleihues P, Ellison DW. The 2016 World Health Organization Classification of Tumors of the Central Nervous System: a summary. Acta Neuropathol. 2016 Jun;131(6):803-20. doi: 10.1007/s00401-016-1545-1. Epub 2016 May 9.
- Background: PubMed 16389942Fischer I, Gagner JP, Law M, Newcomb EW, Zagzag D. Angiogenesis in gliomas: biology and molecular pathophysiology. Brain Pathol. 2005 Oct;15(4):297-310. doi: 10.1111/j.1750-3639.2005.tb00115.x.
- Background: PubMed 16284142Koeller KK, Rushing EJ. From the archives of the AFIP: Oligodendroglioma and its variants: radiologic-pathologic correlation. Radiographics. 2005 Nov-Dec;25(6):1669-88. doi: 10.1148/rg.256055137.
- Results publication: PubMed 24722048Killela PJ, Pirozzi CJ, Healy P, Reitman ZJ, Lipp E, Rasheed BA, Yang R, Diplas BH, Wang Z, Greer PK, Zhu H, Wang CY, Carpenter AB, Friedman H, Friedman AH, Keir ST, He J, He Y, McLendon RE, Herndon JE 2nd, Yan H, Bigner DD. Mutations in IDH1, IDH2, and in the TERT promoter define clinically distinct subgroups of adult malignant gliomas. Oncotarget. 2014 Mar 30;5(6):1515-25. doi: 10.18632/oncotarget.1765.
- Results publication: PubMed 10373119Holash J, Maisonpierre PC, Compton D, Boland P, Alexander CR, Zagzag D, Yancopoulos GD, Wiegand SJ. Vessel cooption, regression, and growth in tumors mediated by angiopoietins and VEGF. Science. 1999 Jun 18;284(5422):1994-8. doi: 10.1126/science.284.5422.1994.
- Results publication: PubMed 18349315Law M, Young RJ, Babb JS, Peccerelli N, Chheang S, Gruber ML, Miller DC, Golfinos JG, Zagzag D, Johnson G. Gliomas: predicting time to progression or survival with cerebral blood volume measurements at dynamic susceptibility-weighted contrast-enhanced perfusion MR imaging. Radiology. 2008 May;247(2):490-8. doi: 10.1148/radiol.2472070898. Epub 2008 Mar 18.
- Results publication: PubMed 19201123Caseiras GB, Chheang S, Babb J, Rees JH, Pecerrelli N, Tozer DJ, Benton C, Zagzag D, Johnson G, Waldman AD, Jager HR, Law M. Relative cerebral blood volume measurements of low-grade gliomas predict patient outcome in a multi-institution setting. Eur J Radiol. 2010 Feb;73(2):215-20. doi: 10.1016/j.ejrad.2008.11.005. Epub 2009 Feb 6.
- Results publication: PubMed 16431890Grobner T. Gadolinium--a specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis? Nephrol Dial Transplant. 2006 Apr;21(4):1104-8. doi: 10.1093/ndt/gfk062. Epub 2006 Jan 23. No abstract available.
- Results publication: PubMed 31548344van der Voort SR, Incekara F, Wijnenga MMJ, Kapas G, Gardeniers M, Schouten JW, Starmans MPA, Nandoe Tewarie R, Lycklama GJ, French PJ, Dubbink HJ, van den Bent MJ, Vincent AJPE, Niessen WJ, Klein S, Smits M. Predicting the 1p/19q Codeletion Status of Presumed Low-Grade Glioma with an Externally Validated Machine Learning Algorithm. Clin Cancer Res. 2019 Dec 15;25(24):7455-7462. doi: 10.1158/1078-0432.CCR-19-1127. Epub 2019 Sep 23.
- Individual participant dataSharing planned: Undecided
Related trials for Glioma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthias JP van Osch, Prof Dr Ir contact
Matthias JP van Osch, Prof Dr Ir principal investigator
Leiden University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma, run by Leiden University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniëlle van Dorth, MSc (+31657056608, D.van_Dorth@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimized MR protocol (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05274919, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.