Application of FET-PET in Fusion With MRI in the Treatment of Glioblastoma Multiforme [TYR-GLIO]

Sponsor
Copernicus Memorial Hospital
Study ID
NCT06466031
Status
Recruiting
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Conditions

  • Glioblastoma Multiforme

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • MRI & PET fusion — OTHER
    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+T1C — OTHER
    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 Details

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.

Key Dates

First listed
Jun 20, 2024
Start date
Dec 8, 2025
Status verified
Apr 2026
Primary completion
Aug 31, 2030
Completion
Aug 31, 2032

Study Design

Enrollment
189 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Resection and radiotherapy according to the MRI & PET fusion
    Surgical treatment and radiotherapy planned based on FET-PET and MRI+T1C fusion.
  • Experimental: Radiotherapy according to the MRI & PET fusion
    Surgical treatment planned based on MRI+T1C study, radiotherapy planned based on FET-PET and MRI+T1C fusion.
  • Sham Comparator: Resection and radiotherapy according to the MRI
    Surgical treatment and radiotherapy planned based on MRI+T1C.

Primary Outcome Measure

Progression-free survival [ Time Frame: 36 months post surgery ]

Central Contacts

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