GlioblastomaGLIMPCENCT07121842
Glioblastoma Imaging for the Detection of Tumor Progression Using APTw-CEST MRI
A study testing Extended MRI in people with Glioblastoma, run by Erasmus Medical Center at 4 sites in Netherlands.
Trial summary
In this study, the invesigators look at how a new MRI technique (called amide proton transfer weighted (APTw) chemical exchange saturation transfer (CEST)) can improve treatment for brain tumors through early detection of tumor progression after radiotherapy and/or chemotherapy treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Extended MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesNetherlands
- Study dates
- 15 Jan 2025to Jul 2027
- Phase
- Interventional
- 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
Who may be able to join
- Confirmed diagnosis of glioblastoma based on histopathological or molecular analysis of biopsy after surgery, or suspected of glioblastoma based on medical imaging.
- Scheduled to undergo radiotherapy or combined chemo-and radiotherapy
- 18 years and older
- Able to give informed consent.
- Patient will undergo clinically indicated MRIs
Who cannot join
- Not able to give informed consent
- Contraindication for MRI
- Brain pathology affecting CEST contrast, such as recent stroke or earlier cranial radiotherapy, as determined by the principal investigators (PIs)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Esther Warnert, PhD, MSc contact
Netherlands4 sites, 4 recruiting
- Not yet recruiting
Amsterdam UMC
Amsterdam
Elsmarieke van de Giessen, PhD, MSc, +31619282386, e.m.vandegiessen@amsterdamumc.nl
- Recruiting
Leiden UMC
Leiden
Chloe Najac, PhD, MSc, +31 71 526 5473, c.f.najac@lumc.nl
- Recruiting
Erasmus MC
Rotterdam
Esther Warnert, PhD, MSc, +31107044124, e.warnert@erasmusmc.nl
- Recruiting
UMC Utrecht
Utrecht
Evita Wiegers, PhD, MSc, +31887553197, e.c.wiegers@umcutrecht.nl
About this study
Official title: GLIMPCE: Glioblastoma Imaging for the Detection of Tumor Progression Using APTw-CEST MRI
In this study, the invesigators look at how a new MRI technique (called amide proton transfer weighted (APTw) chemical exchange saturation transfer (CEST)) can improve treatment for brain tumors through early detection of tumor progression after radiotherapy and/or chemotherapy treatment.
An issue with the current treatment for patients with a brain tumor, is the inability to detect tumor progression early. An abnormality is seen on MRI scans taken shortly after treatment with radiotherapy in about 30% of patients.
Read more
This abnormality may be a sign that radiotherapy treatment has worked well and will disappear on its own after a while. However, an abnormality can also be a sign of active tumor tissue. Then it shows that the treatment has not worked well enough. When there is active tumor tissue, this is called 'tumor progression'. When there is an abnormality that disappears on its own after a while, there is no active tumor tissue. This is called 'pseudoprogression'.
Currently, there are two options to determine whether tumor progression or pseudoprogression has taken place: Do another brain surgery to see if the abnormality contains active tumor tissue or wait and have regular MRI scans until it is clear whether the abnormality goes away on its own.
Amide proton transfer weighted chemical exchange saturation transfer (APTw-CEST) imaging is a new MRI technique in which investigators can produce images that show the accumulation of protein. APTw-CEST has previously been shown to be able to distinguish tumor progression from pseudoprogression earlier than current standard MRI scans. However, these previous studies have drawbacks: they were either done with a small group of patients in 1 hospital, or with a 7 Tesla MRI scanner, a rare type of scanner not standard in hospitals, or done in animal models.
In this research project the investigators now want to prepare APTw-CEST for standard patient care for patients with glioblastoma in the Netherlands so that in the future APTw-CEST can be included as a standard scan during treatment. The investigators are doing this by introducing APTw-CEST MRI on the clinical MRI scanners of four different hospitals. Ultimately, the investigators want to use this to create national guidelines for measuring and viewing APTw-CEST MRI images for early detection of tumor progression.
Read the detailed description
Rationale:
A major issue with glioblastoma treatment is the occurrence of contrast enhancement after treatment with radiotherapy or chemoradiotherapy. This enhancement can be due to more tumor growth; called true progression. It can also be due to treatment-related effects; called pseudoprogression. Amide proton transfer weighted (APTw) chemical exchange saturation transfer (CEST) magnetic resonance imaging (MRI) is a technique that indirectly images proteins and peptides in a tissue. Because these molecules are overexpressed in tumor tissue, APTw-CEST MRI has been shown to be good at distinguishing between true progression and pseudoprogression, which is important as they require vastly different responses. This technique shows promise to become an important biomarker in glioblastoma treatment, how-ever it currently lacks standardization, as studies are generally done in one center on MRI machines of one vendor.
This multi-center study will make APTw-CEST MRI a clinically usable biomarker for the detection of tumor progression in glioblastoma patients by providing acquisition and post-processing recommendations, as well as a threshold on APTw-CEST images that would allow a clinician to accurately distinguish between pseudoprogression and true progression, regard-less of where the images were acquired and with which system.
The underlying processes that make APTw-CEST a reliable biomarker for glioblastoma treatment response evaluation are not clearly known. Using other advanced MRI techniques (diffusion, perfusion) and O-(2-[18F]fluoroethyl-)-L-tyrosine Positron Emission Tomography (FET-PET), and correlating these images with the APTw-CEST images will give a better insight into these processes.
Primary Objective: Determine the optimal threshold on APTw-CEST images in a multi-center (4 academic institutes) multi-vendor (Philips, Siemens and GE) clinical trial, to distinguish tumor progression from treatment-related effects.
Secondary Objective(s):
- Correlate APTw-CEST MRI to complimentary, advanced imaging parameters such as FET-PET, diffusion and perfusion MRI, and Response Assessment for Neuro-Oncology (RANO) criteria.
- Provide recommendations for the acquisition and post-processing of APTw-CEST MRI.
Study design:
In this prospective cohort study, all clinical MRI scans will be extended with the APTw-CEST protocol. The patient receives their standard care and decisions will be made based on standard-of-care imaging. The APTw-CEST images and diagnosis from standard follow-up will be used to determine the threshold on APTw-CEST images that would most accurately distinguish between pseudoprogression and true progression early after treatment.
Additional advanced imaging (diffusion, perfusion, FET-PET) taken during the treatment and follow-up of the patient will be used to correlate areas of high APTw signal with other signals.
Study population: 120 patients diagnosed with or suspected of glioblastoma using molecular or histochemistry analysis or medical imaging respectively.
Intervention (if applicable): Each patient will have extensions to all MRI scans taken for the treatment and follow-up of glioblastoma. The APTw-CEST sequence will be added to all clinical scans, for an addition of 10-15 minutes of scan time.
Main study parameters/endpoints: Threshold on APTw-CEST images that accurately distinguishes between true progression and pseudoprogression in recently treated glioblastoma patients. The accuracy will be optimized using Receiver operating characteristic (ROC) curve analysis and the Youden index.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The clinical care of the patient group will not be altered. The APTw-CEST images will not be used to make any clinical decision. Patients will not have personal benefit from this study, and will have the burden of a prolonged scan time of 10-15 minutes. All further imaging used in this study; perfusion, diffusion and FET-PET will not be taken specifically for this study and will only be taken when clinically indicated, except in LUMC where the FET-PET will be added to standard-of-care. The addition of FET-PET in the patient group in LUMC is warranted as the long-term risks are negligible for this patient group, due to the median survival of 12-14 months.
- Conditions
- Glioblastoma
- Being tested
- Extended MRI
- Keywords
- Glioblastoma, MRI, CEST, Pseudoprogression, multi-center, APTw-CEST
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended MRIDiagnostic test
The MRI protocol for every clinical follow-up MRI scan is extended with 15 minutes to add the APTw-CEST scan.
| Study group | Role | What they receive |
|---|---|---|
| Extended MRI | Other | The MRI protocol for every clinical MRI scan taken in follow-up is extended with 15 minutes. Receives: Diagnostic Test: Extended MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining the Threshold
Determine the optimal threshold on APTw-CEST images in a multi-center (4 aca-demic institutes) multi-vendor (Philips, Siemens and GE) clinical trial, to distinguish tumor progression from treatment-related effects.
Measured: Until 1 year after the first MRI scan with the additional APTw-CEST added
Secondary outcomes (1)
Correlations with other MRI and PET scans.
Correlate APTw-CEST MRI to complimentary, advanced imaging parameters such as FET-PET, diffusion and perfusion MRI, and RANO criteria.
Measured: Up until 1 year from the date of the first MRI scan with added APTw-CEST
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start15 Jan 2025
- Primary completionJan 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Erasmus 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht, LeidenUMC, Amsterdam UMC, location VUmc
- Responsible party
- Principal investigator, Esther Warnert, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121842
- Sponsor's protocol ID
- NL86895.078.24
- Acronym
- GLIMPCE
- Status last verified
- Aug 2025
- First submitted
- 31 Jul 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLIMPCE: Glioblastoma Imaging for the Detection of Tumor Progression Using APTw-CEST MRI
- ClinicalTrials.gov ID
- NCT07121842
- Acronym / sponsor ID
- GLIMPCE / NL86895.078.24
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, MRI, CEST, Pseudoprogression, multi-center, APTw-CEST
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- UMC Utrecht, LeidenUMC, Amsterdam UMC, location VUmc
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 14 Aug 2025 (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.
In this study, the invesigators look at how a new MRI technique (called amide proton transfer weighted (APTw) chemical exchange saturation transfer (CEST)) can improve treatment for brain tumors through early detection of tumor progression after radiotherapy and/or chemotherapy treatment.
An issue with the current treatment for patients with a brain tumor, is the inability to detect tumor progression early. An abnormality is seen on MRI scans taken shortly after treatment with radiotherapy in about 30% of patients.
This abnormality may be a sign that radiotherapy treatment has worked well and will disappear on its own after a while. However, an abnormality can also be a sign of active tumor tissue. Then it shows that the treatment has not worked well enough. When there is active tumor tissue, this is called 'tumor progression'. When there is an abnormality that disappears on its own after a while, there is no active tumor tissue. This is called 'pseudoprogression'.
Currently, there are two options to determine whether tumor progression or pseudoprogression has taken place: Do another brain surgery to see if the abnormality contains active tumor tissue or wait and have regular MRI scans until it is clear whether the abnormality goes away on its own.
Amide proton transfer weighted chemical exchange saturation transfer (APTw-CEST) imaging is a new MRI technique in which investigators can produce images that show the accumulation of protein. APTw-CEST has previously been shown to be able to distinguish tumor progression from pseudoprogression earlier than current standard MRI scans. However, these previous studies have drawbacks: they were either done with a small group of patients in 1 hospital, or with a 7 Tesla MRI scanner, a rare type of scanner not standard in hospitals, or done in animal models.
In this research project the investigators now want to prepare APTw-CEST for standard patient care for patients with glioblastoma in the Netherlands so that in the future APTw-CEST can be included as a standard scan during treatment. The investigators are doing this by introducing APTw-CEST MRI on the clinical MRI scanners of four different hospitals. Ultimately, the investigators want to use this to create national guidelines for measuring and viewing APTw-CEST MRI images for early detection of tumor progression.
Detailed description
Rationale:
A major issue with glioblastoma treatment is the occurrence of contrast enhancement after treatment with radiotherapy or chemoradiotherapy. This enhancement can be due to more tumor growth; called true progression. It can also be due to treatment-related effects; called pseudoprogression. Amide proton transfer weighted (APTw) chemical exchange saturation transfer (CEST) magnetic resonance imaging (MRI) is a technique that indirectly images proteins and peptides in a tissue. Because these molecules are overexpressed in tumor tissue, APTw-CEST MRI has been shown to be good at distinguishing between true progression and pseudoprogression, which is important as they require vastly different responses. This technique shows promise to become an important biomarker in glioblastoma treatment, how-ever it currently lacks standardization, as studies are generally done in one center on MRI machines of one vendor.
This multi-center study will make APTw-CEST MRI a clinically usable biomarker for the detection of tumor progression in glioblastoma patients by providing acquisition and post-processing recommendations, as well as a threshold on APTw-CEST images that would allow a clinician to accurately distinguish between pseudoprogression and true progression, regard-less of where the images were acquired and with which system.
The underlying processes that make APTw-CEST a reliable biomarker for glioblastoma treatment response evaluation are not clearly known. Using other advanced MRI techniques (diffusion, perfusion) and O-(2-[18F]fluoroethyl-)-L-tyrosine Positron Emission Tomography (FET-PET), and correlating these images with the APTw-CEST images will give a better insight into these processes.
Primary Objective: Determine the optimal threshold on APTw-CEST images in a multi-center (4 academic institutes) multi-vendor (Philips, Siemens and GE) clinical trial, to distinguish tumor progression from treatment-related effects.
Secondary Objective(s):
- Correlate APTw-CEST MRI to complimentary, advanced imaging parameters such as FET-PET, diffusion and perfusion MRI, and Response Assessment for Neuro-Oncology (RANO) criteria.
- Provide recommendations for the acquisition and post-processing of APTw-CEST MRI.
Study design:
In this prospective cohort study, all clinical MRI scans will be extended with the APTw-CEST protocol. The patient receives their standard care and decisions will be made based on standard-of-care imaging. The APTw-CEST images and diagnosis from standard follow-up will be used to determine the threshold on APTw-CEST images that would most accurately distinguish between pseudoprogression and true progression early after treatment.
Additional advanced imaging (diffusion, perfusion, FET-PET) taken during the treatment and follow-up of the patient will be used to correlate areas of high APTw signal with other signals.
Study population: 120 patients diagnosed with or suspected of glioblastoma using molecular or histochemistry analysis or medical imaging respectively.
Intervention (if applicable): Each patient will have extensions to all MRI scans taken for the treatment and follow-up of glioblastoma. The APTw-CEST sequence will be added to all clinical scans, for an addition of 10-15 minutes of scan time.
Main study parameters/endpoints: Threshold on APTw-CEST images that accurately distinguishes between true progression and pseudoprogression in recently treated glioblastoma patients. The accuracy will be optimized using Receiver operating characteristic (ROC) curve analysis and the Youden index.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The clinical care of the patient group will not be altered. The APTw-CEST images will not be used to make any clinical decision. Patients will not have personal benefit from this study, and will have the burden of a prolonged scan time of 10-15 minutes. All further imaging used in this study; perfusion, diffusion and FET-PET will not be taken specifically for this study and will only be taken when clinically indicated, except in LUMC where the FET-PET will be added to standard-of-care. The addition of FET-PET in the patient group in LUMC is warranted as the long-term risks are negligible for this patient group, due to the median survival of 12-14 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extended MRI | Other | Diagnostic Test: Extended MRIThe MRI protocol for every clinical MRI scan taken in follow-up is extended with 15 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of glioblastoma based on histopathological or molecular analysis of biopsy after surgery, or suspected of glioblastoma based on medical imaging.
- Scheduled to undergo radiotherapy or combined chemo-and radiotherapy
- 18 years and older
- Able to give informed consent.
- Patient will undergo clinically indicated MRIs
Key exclusion criteria (3 listed)
- Not able to give informed consent
- Contraindication for MRI
- Brain pathology affecting CEST contrast, such as recent stroke or earlier cranial radiotherapy, as determined by the principal investigators (PIs)
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 |
|---|---|---|
| Extended MRIThe MRI protocol for every clinical follow-up MRI scan is extended with 15 minutes to add the APTw-CEST scan. | Diagnostic test | Extended MRI |
Primary outcome
Determining the Threshold
Time frame: Until 1 year after the first MRI scan with the additional APTw-CEST added
Determine the optimal threshold on APTw-CEST images in a multi-center (4 aca-demic institutes) multi-vendor (Philips, Siemens and GE) clinical trial, to distinguish tumor progression from treatment-related effects.
1 secondary outcome
Correlations with other MRI and PET scans.
Time frame: Up until 1 year from the date of the first MRI scan with added APTw-CEST
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 14 Aug 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Esther Warnert, PhD, MSc contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended MRI in people with Glioblastoma, run by Erasmus Medical Center at 4 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 3 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 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 Laura Kemper, MSc (+310630720232, l.kemper@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining the Threshold (time frame: Until 1 year after the first MRI scan with the additional APTw-CEST added). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2025.