Glioblastoma MultiformeTYR-GLIONCT06466031
Application of FET-PET in Fusion With MRI in the Treatment of Glioblastoma Multiforme [TYR-GLIO]
A study testing MRI & PET fusion and MRI+T1C in people with Glioblastoma Multiforme, run by Copernicus Memorial Hospital at 1 site in Poland.
Trial summary
Glioblastoma multiforme (GBM WHO IV) is the most common and aggressive primary brain tumor in adults, carrying a poor prognosis with a median survival of 12-16 months. The annual incidence is approximately 5 per 100,000 (roughly 600 cases annually in Poland), predominantly affecting individuals in their prime… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- MRI & PET fusion and MRI+T1C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 1 sitePoland
- Study dates
- 8 Dec 2025to 31 Aug 2032
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single macroscopic tumor focus with the appearance of glioblastoma multiforme on MRI with contrast - contrast-enhancing lesion, completely or with central necrosis, with surrounding edema.
- No history of cancer in other organs. No suspicious lesions on X-ray of the chest and abdomen (CT with contrast).
- No clinical suspicion of brain abscess - no meningeal symptoms, signs of neuroinfection, fever, elevated inflammatory parameters.
- Primary tumor, without neurosurgical, radiotherapy or oncology intervention. Prior tumor biopsy is allowed.
- Tumor eligible for surgical treatment - craniotomy and tumor resection.
- Age ≥ 18 years but < 70 years old.
Show all 10Show fewer
- Quality of life assessment: KPS ≥ 70.
- Informed patient consent to the study and proposed treatment.
- No allergy to contrast agents used in PET and MRI.
- No medical contraindications to neurosurgery - craniotomy and resection.
Who cannot join
- Multifocal brain tumor.
- Recurrence of glioblastoma multiforme.
- Clinical or radiological suspicion of brain metastasis or brain abscess.
- Postoperative histopathological diagnosis other than WHO grade IV glioblastoma.
- Medical contraindications to any surgery under general anesthesia.
- Pregnancy, breastfeeding.
- Known allergy to gadolinium contrast or radiopharmaceutical tracing agent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Copernicus Memorial Hospital in Łódź, Poland
Lodz, Łódź Voivodeship, 93-513
Kamil Krystkiewicz, PhD, +48426895341, kamil.krystkiewicz@gmail.com
Kamil Krystkiewicz, PhD
About this study
Official title: Application of FET-PET in Fusion With MRI in the Surgical Treatment and Postoperative Radiotherapy of Glioblastoma Multiforme - a Randomized, Blinded, Prospective Study
Glioblastoma multiforme (GBM WHO IV) is the most common and aggressive primary brain tumor in adults, carrying a poor prognosis with a median survival of 12-16 months. The annual incidence is approximately 5 per 100,000 (roughly 600 cases annually in Poland), predominantly affecting individuals in their prime productive years. The standard of care consists of maximal safe resection followed by the Stupp protocol (60 Gy fractionated radiotherapy and temozolomide chemotherapy).
Routine surgical management relies on contrast-enhanced MRI. Gross total resection (GTR) is defined as the complete removal of the contrast-enhancing lesion. Although GTR improves progression-free survival (PFS) and overall survival (OS), local recurrence at the operative site occurs in up to 51% of patients within a year. This rapid regrowth is driven by glioblastoma stem cells infiltrating the surrounding non-enhancing brain tissue. Consequently, standard contrast-enhanced MRI lacks the sensitivity required to define true tumor boundaries for optimal patient outcomes.
Read more
To overcome this, positron emission tomography (PET-CT) using amino acid tracers like 18F-fluoroethyl-L-tyrosine (18F-FET) offers a promising alternative. Unlike 18-FDG, which is obscured by physiologically high glucose uptake in healthy brain tissue, 18F-FET provides high specificity and sensitivity for glial tumors. Crucially, studies show that MRI contrast enhancement overlaps with only 58% of the hypermetabolic area identified by 18F-FET. While "supramarginal" resections based on FLAIR MRI abnormalities (assumed to contain infiltrating stem cells) improve PFS by roughly 2 months, the FLAIR sequence cannot definitively distinguish active tumor infiltration from standard peritumoral edema.
This proposed experiment carries significant innovative value: it aims to use the fusion of 18F-FET PET and contrast-enhanced MRI to precisely guide both primary surgical resection and postoperative radiotherapy. By redefining the primary target volume to include the area of true biological tumor activity rather than just the MRI-enhancing mass (incorporating it into GTV, CTV, and PTV planning), the procedure directly targets residual glioblastoma stem cells. While PET has been evaluated for radiotherapy planning in recurrent GBM, high-quality data regarding its use for primary surgical planning is lacking. This study aims to fill that crucial gap in the literature.
- Conditions
- Glioblastoma Multiforme
- Being tested
- MRI & PET fusion, MRI+T1C
- Keywords
- Glioblastoma Multiforme, Methionine, Positron-Emission Tomography, Brain neoplasms, Progression-free survival, Dose Fractionation, Radiation, Post-surgical radiotherapy
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI & PET fusionOther
MRI+T1C in fusion with FET-PET will be used for tumor resection and/or radiotherapy planning. Resection will be terminated after removal of PET-assigned tumor margin or in case any neuromonitoring-based indications regarding neurological damage occur.
MRI+T1COther
MRI+T1C will be used for tumor resection and radiotherapy planning. Resection will be terminated after removal of contrast-enhancing part regardless of 5-ALA fluorescence or in case any neuromonitoring-based indications regarding neurological damage occur.
| Study group | Role | What they receive |
|---|---|---|
| Resection and radiotherapy according to the MRI & PET fusion | Experimental | Surgical treatment and radiotherapy planned based on FET-PET and MRI+T1C fusion. Receives: Other: MRI & PET fusion |
| Radiotherapy according to the MRI & PET fusion | Experimental | Surgical treatment planned based on MRI+T1C study, radiotherapy planned based on FET-PET and MRI+T1C fusion. Receives: Other: MRI & PET fusion; Other: MRI+T1C |
| Resection and radiotherapy according to the MRI | Sham comparator | Surgical treatment and radiotherapy planned based on MRI+T1C. Receives: Other: MRI+T1C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 36 months post surgery
Overall survival
Measured: 36 months post surgery
Secondary outcomes (5)
Assessment of tumor volume (GTV) in MRI with contrast in relation to the tumor borders in PET-CT
It will be assessed as the ratio of the treated tumor volume volumetrically based on MRI+T1C and FLAIR examination by software to the tumor volume estimated in a homogeneous way based on PET-CT examination. Both measurements will be verified independently by a neurosurgeon and a nuclear medicine specialist. This value will allow you to estimate how large the differences are treatment planning based on two different modalities - morphological assessment of the tumor and assessment of metabolic activity.
Measured: 1 day before radiotherapy
Volumetric assessment of the planned radiotherapy volume based on PET-MRI and MRI planning.
Measured: 1 day before radiotherapy
Long-term survival rate and prognostic factors (longer than 1 year from diagnosis).
Detailed analysis of factors prognostically favorable for long-term survival, which will allow for better selection of therapeutic options and possible reoperation in this group of patients.
Measured: 36 months post surgery
Pattern of local recurrence based on postoperative PET-MRI. Assessment of the nature and location of local recurrence based on the postoperative SUV parameter FET-PET and MRI examination.
The purpose of this analysis is to develop risk factors for recurrence based on postoperative radiological examinations.
Measured: 36 months post surgery
Assessment of quality of life related (SF-36 questionnaire) to the increase in the volume of the tumor undergoing treatment.
Increasing the scope surgery and radiotherapy treatment may result in deterioration of the patient's functioning. Therefore, the above factors will be analyzed for correlation the scope of resection and the functioning of patients. The evaluation will be performed by neurosurgeons and a psychologist trained in neuropsychological assessment.
Measured: 7 days post surgery, 1 day before and after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start8 Dec 2025
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Aug 2032 (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 Glioblastoma MultiformeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copernicus Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Responsible party
- Principal investigator, Kamil Krystkiewicz, Copernicus Memorial Hospital
- Investigators
- Kamil Krystkiewicz, PhD, Principal investigator, Department of Neurosurgery and Neurooncology, Copernicus Memorial Hospital in Łódź, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466031
- Sponsor's protocol ID
- 2023/ABM/01/00010
- Acronym
- TYR-GLIO
- Status last verified
- Apr 2026
- First submitted
- 2 Jun 2024
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hutterer M, Nowosielski M, Putzer D, Jansen NL, Seiz M, Schocke M, McCoy M, Gobel G, la Fougere C, Virgolini IJ, Trinka E, Jacobs AH, Stockhammer G. [18F]-fluoro-ethyl-L-tyrosine PET: a valuable diagnostic tool in neuro-oncology, but not all that glitters is glioma. Neuro Oncol. 2013 Mar;15(3):341-51. doi: 10.1093/neuonc/nos300. Epub 2013 Jan 17.
PubMed 23335162Dunet V, Pomoni A, Hottinger A, Nicod-Lalonde M, Prior JO. Performance of 18F-FET versus 18F-FDG-PET for the diagnosis and grading of brain tumors: systematic review and meta-analysis. Neuro Oncol. 2016 Mar;18(3):426-34. doi: 10.1093/neuonc/nov148. Epub 2015 Aug 4.
PubMed 26243791Robert JA, Leclerc A, Ducloie M, Emery E, Agostini D, Vigne J. Contribution of [18F]FET PET in the Management of Gliomas, from Diagnosis to Follow-Up: A Review. Pharmaceuticals (Basel). 2024 Sep 18;17(9):1228. doi: 10.3390/ph17091228.
PubMed 39338390Ort J, Hamou HA, Kernbach JM, Hakvoort K, Blume C, Lohmann P, Galldiks N, Heiland DH, Mottaghy FM, Clusmann H, Neuloh G, Langen KJ, Delev D. 18F-FET-PET-guided gross total resection improves overall survival in patients with WHO grade III/IV glioma: moving towards a multimodal imaging-guided resection. J Neurooncol. 2021 Oct;155(1):71-80. doi: 10.1007/s11060-021-03844-1. Epub 2021 Oct 1.
PubMed 34599479Harat M, Rakowska J, Harat M, Szylberg T, Furtak J, Miechowicz I, Malkowski B. Combining amino acid PET and MRI imaging increases accuracy to define malignant areas in adult glioma. Nat Commun. 2023 Jul 29;14(1):4572. doi: 10.1038/s41467-023-39731-8.
PubMed 37516762Herholz K, Holzer T, Bauer B, Schroder R, Voges J, Ernestus RI, Mendoza G, Weber-Luxenburger G, Lottgen J, Thiel A, Wienhard K, Heiss WD. 11C-methionine PET for differential diagnosis of low-grade gliomas. Neurology. 1998 May;50(5):1316-22. doi: 10.1212/wnl.50.5.1316.
PubMed 9595980Kracht LW, Miletic H, Busch S, Jacobs AH, Voges J, Hoevels M, Klein JC, Herholz K, Heiss WD. Delineation of brain tumor extent with [11C]L-methionine positron emission tomography: local comparison with stereotactic histopathology. Clin Cancer Res. 2004 Nov 1;10(21):7163-70. doi: 10.1158/1078-0432.CCR-04-0262.
PubMed 15534088Singhal T, Narayanan TK, Jain V, Mukherjee J, Mantil J. 11C-L-methionine positron emission tomography in the clinical management of cerebral gliomas. Mol Imaging Biol. 2008 Jan-Feb;10(1):1-18. doi: 10.1007/s11307-007-0115-2. Epub 2007 Oct 24.
PubMed 17957408Grosu AL, Weber WA, Riedel E, Jeremic B, Nieder C, Franz M, Gumprecht H, Jaeger R, Schwaiger M, Molls M. L-(methyl-11C) methionine positron emission tomography for target delineation in resected high-grade gliomas before radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Sep 1;63(1):64-74. doi: 10.1016/j.ijrobp.2005.01.045.
PubMed 16111573Galldiks N, Niyazi M, Grosu AL, Kocher M, Langen KJ, Law I, Minniti G, Kim MM, Tsien C, Dhermain F, Soffietti R, Mehta MP, Weller M, Tonn JC. Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients - a report of the PET/RANO group. Neuro Oncol. 2021 Jun 1;23(6):881-893. doi: 10.1093/neuonc/noab013.
PubMed 33538838Pirotte B, Goldman S, Dewitte O, Massager N, Wikler D, Lefranc F, Ben Taib NO, Rorive S, David P, Brotchi J, Levivier M. Integrated positron emission tomography and magnetic resonance imaging-guided resection of brain tumors: a report of 103 consecutive procedures. J Neurosurg. 2006 Feb;104(2):238-53. doi: 10.3171/jns.2006.104.2.238.
PubMed 16509498
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of FET-PET in Fusion With MRI in the Surgical Treatment and Postoperative Radiotherapy of Glioblastoma Multiforme - a Randomized, Blinded, Prospective Study
- ClinicalTrials.gov ID
- NCT06466031
- Acronym / sponsor ID
- TYR-GLIO / 2023/ABM/01/00010
- Conditions
- Glioblastoma Multiforme
- Keywords
- Glioblastoma Multiforme, Methionine, Positron-Emission Tomography, Brain neoplasms, Progression-free survival, Dose Fractionation, Radiation, Post-surgical radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Copernicus Memorial HospitalUniversity, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 31 Aug 2030 (estimated)
- Study completion
- 31 Aug 2032 (estimated)
- First posted
- 20 Jun 2024 (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.
Glioblastoma multiforme (GBM WHO IV) is the most common and aggressive primary brain tumor in adults, carrying a poor prognosis with a median survival of 12-16 months. The annual incidence is approximately 5 per 100,000 (roughly 600 cases annually in Poland), predominantly affecting individuals in their prime productive years. The standard of care consists of maximal safe resection followed by the Stupp protocol (60 Gy fractionated radiotherapy and temozolomide chemotherapy).
Routine surgical management relies on contrast-enhanced MRI. Gross total resection (GTR) is defined as the complete removal of the contrast-enhancing lesion. Although GTR improves progression-free survival (PFS) and overall survival (OS), local recurrence at the operative site occurs in up to 51% of patients within a year. This rapid regrowth is driven by glioblastoma stem cells infiltrating the surrounding non-enhancing brain tissue. Consequently, standard contrast-enhanced MRI lacks the sensitivity required to define true tumor boundaries for optimal patient outcomes.
To overcome this, positron emission tomography (PET-CT) using amino acid tracers like 18F-fluoroethyl-L-tyrosine (18F-FET) offers a promising alternative. Unlike 18-FDG, which is obscured by physiologically high glucose uptake in healthy brain tissue, 18F-FET provides high specificity and sensitivity for glial tumors. Crucially, studies show that MRI contrast enhancement overlaps with only 58% of the hypermetabolic area identified by 18F-FET. While "supramarginal" resections based on FLAIR MRI abnormalities (assumed to contain infiltrating stem cells) improve PFS by roughly 2 months, the FLAIR sequence cannot definitively distinguish active tumor infiltration from standard peritumoral edema.
This proposed experiment carries significant innovative value: it aims to use the fusion of 18F-FET PET and contrast-enhanced MRI to precisely guide both primary surgical resection and postoperative radiotherapy. By redefining the primary target volume to include the area of true biological tumor activity rather than just the MRI-enhancing mass (incorporating it into GTV, CTV, and PTV planning), the procedure directly targets residual glioblastoma stem cells. While PET has been evaluated for radiotherapy planning in recurrent GBM, high-quality data regarding its use for primary surgical planning is lacking. This study aims to fill that crucial gap in the literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resection and radiotherapy according to the MRI & PET fusion | Experimental | Other: MRI & PET fusionSurgical treatment and radiotherapy planned based on FET-PET and MRI+T1C fusion. |
| Radiotherapy according to the MRI & PET fusion | Experimental | Other: MRI & PET fusion, Other: MRI+T1CSurgical treatment planned based on MRI+T1C study, radiotherapy planned based on FET-PET and MRI+T1C fusion. |
| Resection and radiotherapy according to the MRI | Sham comparator | Other: MRI+T1CSurgical treatment and radiotherapy planned based on MRI+T1C. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Single macroscopic tumor focus with the appearance of glioblastoma multiforme on MRI with contrast - contrast-enhancing lesion, completely or with central necrosis, with surrounding edema.
- No history of cancer in other organs. No suspicious lesions on X-ray of the chest and abdomen (CT with contrast).
- No clinical suspicion of brain abscess - no meningeal symptoms, signs of neuroinfection, fever, elevated inflammatory parameters.
- Primary tumor, without neurosurgical, radiotherapy or oncology intervention. Prior tumor biopsy is allowed.
- Tumor eligible for surgical treatment - craniotomy and tumor resection.
Key exclusion criteria (7 listed)
- Multifocal brain tumor.
- Recurrence of glioblastoma multiforme.
- Clinical or radiological suspicion of brain metastasis or brain abscess.
- Postoperative histopathological diagnosis other than WHO grade IV glioblastoma.
- Medical contraindications to any surgery under general anesthesia.
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 |
|---|---|---|
| MRI & PET fusionMRI+T1C in fusion with FET-PET will be used for tumor resection and/or radiotherapy planning. Resection will be terminated after removal of PET-assigned tumor margin or in case any neuromonitoring-based indications regarding neurological damage occur. | Other | Radiotherapy according to the MRI & PET fusion, Resection and radiotherapy according to the MRI & PET fusion |
| MRI+T1CMRI+T1C will be used for tumor resection and radiotherapy planning. Resection will be terminated after removal of contrast-enhancing part regardless of 5-ALA fluorescence or in case any neuromonitoring-based indications regarding neurological damage occur. | Other | Radiotherapy according to the MRI & PET fusion, Resection and radiotherapy according to the MRI |
Primary outcome
Progression-free survival
Time frame: 36 months post surgery
Overall survival
Time frame: 36 months post surgery
5 secondary outcomes
Assessment of tumor volume (GTV) in MRI with contrast in relation to the tumor borders in PET-CT
Time frame: 1 day before radiotherapy
Volumetric assessment of the planned radiotherapy volume based on PET-MRI and MRI planning.
Time frame: 1 day before radiotherapy
Long-term survival rate and prognostic factors (longer than 1 year from diagnosis).
Time frame: 36 months post surgery
Pattern of local recurrence based on postoperative PET-MRI. Assessment of the nature and location of local recurrence based on the postoperative SUV parameter FET-PET and MRI examination.
Time frame: 36 months post surgery
Assessment of quality of life related (SF-36 questionnaire) to the increase in the volume of the tumor undergoing treatment.
Time frame: 7 days post surgery, 1 day before and after radiotherapy
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 17 Apr 2026.
- Background: PubMed 23335162Hutterer M, Nowosielski M, Putzer D, Jansen NL, Seiz M, Schocke M, McCoy M, Gobel G, la Fougere C, Virgolini IJ, Trinka E, Jacobs AH, Stockhammer G. [18F]-fluoro-ethyl-L-tyrosine PET: a valuable diagnostic tool in neuro-oncology, but not all that glitters is glioma. Neuro Oncol. 2013 Mar;15(3):341-51. doi: 10.1093/neuonc/nos300. Epub 2013 Jan 17.
- Background: PubMed 26243791Dunet V, Pomoni A, Hottinger A, Nicod-Lalonde M, Prior JO. Performance of 18F-FET versus 18F-FDG-PET for the diagnosis and grading of brain tumors: systematic review and meta-analysis. Neuro Oncol. 2016 Mar;18(3):426-34. doi: 10.1093/neuonc/nov148. Epub 2015 Aug 4.
- Background: PubMed 39338390Robert JA, Leclerc A, Ducloie M, Emery E, Agostini D, Vigne J. Contribution of [18F]FET PET in the Management of Gliomas, from Diagnosis to Follow-Up: A Review. Pharmaceuticals (Basel). 2024 Sep 18;17(9):1228. doi: 10.3390/ph17091228.
- Background: PubMed 34599479Ort J, Hamou HA, Kernbach JM, Hakvoort K, Blume C, Lohmann P, Galldiks N, Heiland DH, Mottaghy FM, Clusmann H, Neuloh G, Langen KJ, Delev D. 18F-FET-PET-guided gross total resection improves overall survival in patients with WHO grade III/IV glioma: moving towards a multimodal imaging-guided resection. J Neurooncol. 2021 Oct;155(1):71-80. doi: 10.1007/s11060-021-03844-1. Epub 2021 Oct 1.
- Background: PubMed 37516762Harat M, Rakowska J, Harat M, Szylberg T, Furtak J, Miechowicz I, Malkowski B. Combining amino acid PET and MRI imaging increases accuracy to define malignant areas in adult glioma. Nat Commun. 2023 Jul 29;14(1):4572. doi: 10.1038/s41467-023-39731-8.
- Background: PubMed 9595980Herholz K, Holzer T, Bauer B, Schroder R, Voges J, Ernestus RI, Mendoza G, Weber-Luxenburger G, Lottgen J, Thiel A, Wienhard K, Heiss WD. 11C-methionine PET for differential diagnosis of low-grade gliomas. Neurology. 1998 May;50(5):1316-22. doi: 10.1212/wnl.50.5.1316.
- Background: PubMed 15534088Kracht LW, Miletic H, Busch S, Jacobs AH, Voges J, Hoevels M, Klein JC, Herholz K, Heiss WD. Delineation of brain tumor extent with [11C]L-methionine positron emission tomography: local comparison with stereotactic histopathology. Clin Cancer Res. 2004 Nov 1;10(21):7163-70. doi: 10.1158/1078-0432.CCR-04-0262.
- Background: PubMed 17957408Singhal T, Narayanan TK, Jain V, Mukherjee J, Mantil J. 11C-L-methionine positron emission tomography in the clinical management of cerebral gliomas. Mol Imaging Biol. 2008 Jan-Feb;10(1):1-18. doi: 10.1007/s11307-007-0115-2. Epub 2007 Oct 24.
- Background: PubMed 16111573Grosu AL, Weber WA, Riedel E, Jeremic B, Nieder C, Franz M, Gumprecht H, Jaeger R, Schwaiger M, Molls M. L-(methyl-11C) methionine positron emission tomography for target delineation in resected high-grade gliomas before radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Sep 1;63(1):64-74. doi: 10.1016/j.ijrobp.2005.01.045.
- Background: PubMed 33538838Galldiks N, Niyazi M, Grosu AL, Kocher M, Langen KJ, Law I, Minniti G, Kim MM, Tsien C, Dhermain F, Soffietti R, Mehta MP, Weller M, Tonn JC. Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients - a report of the PET/RANO group. Neuro Oncol. 2021 Jun 1;23(6):881-893. doi: 10.1093/neuonc/noab013.
- Background: PubMed 16509498Pirotte B, Goldman S, Dewitte O, Massager N, Wikler D, Lefranc F, Ben Taib NO, Rorive S, David P, Brotchi J, Levivier M. Integrated positron emission tomography and magnetic resonance imaging-guided resection of brain tumors: a report of 103 consecutive procedures. J Neurosurg. 2006 Feb;104(2):238-53. doi: 10.3171/jns.2006.104.2.238.
- Individual participant dataSharing planned: No
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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.
Kamil Krystkiewicz, PhD principal investigator
Department of Neurosurgery and Neurooncology, Copernicus Memorial Hospital in Łódź, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI & PET fusion and MRI+T1C in people with Glioblastoma Multiforme, run by Copernicus Memorial Hospital at 1 site in Poland.
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 10 inclusion and 7 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 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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. Some participants in this study may receive a placebo. 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 Kamil Krystkiewicz, PhD (+48426895341, kamil.krystkiewicz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 36 months post surgery). The study lists 2 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 NCT06466031, 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 17 Apr 2026.