Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06466031

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

Led by Copernicus Memorial Hospital · Updated on 2026-04-17

189

Participants Needed

1

Research Sites

351 weeks

Total Duration

On this page

Sponsors

C

Copernicus Memorial Hospital

Lead Sponsor

M

Medical Research Agency, Poland

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Single macroscopic tumor focus appearing as glioblastoma multiforme on contrast-enhanced MRI, with or without central necrosis and surrounding edema
  • No history of cancer in other organs and no suspicious lesions on chest and abdomen X-ray or CT with contrast
  • No clinical signs of brain abscess or infection such as meningeal symptoms, fever, or elevated inflammatory markers
  • Primary tumor without prior neurosurgical, radiotherapy, or oncology treatment (prior biopsy allowed)
  • Tumor suitable for surgical treatment by craniotomy and resection
  • Age 18 years or older but less than 70 years
  • Karnofsky Performance Status score of 70 or higher
  • Informed consent given for study participation and proposed treatment
  • No allergy to contrast agents used in PET and MRI
  • No medical contraindications to neurosurgery including craniotomy and tumor resection
Not Eligible

You will not qualify if you...

  • 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 or breastfeeding
  • Known allergy to gadolinium contrast or radiopharmaceutical tracing agent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Copernicus Memorial Hospital in Łódź, Poland

Lodz, Łódź Voivodeship, Poland, 93-513

Actively Recruiting

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Research Team

K

Kamil Krystkiewicz, PhD

CONTACT

M

Marcin Tosik, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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