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

April 14, 2026 updated by: Kamil Krystkiewicz, Copernicus Memorial Hospital

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.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

189

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 93-513
        • Recruiting
        • Copernicus Memorial Hospital in Łódź, Poland
        • Contact:
        • Principal Investigator:
          • Kamil Krystkiewicz, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resection and radiotherapy according to the MRI & PET fusion
Surgical treatment and radiotherapy planned based on FET-PET and MRI+T1C fusion.
Other: MRI & PET fusion
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.
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.
Other: MRI+T1C
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.
Other: MRI & PET fusion
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.
Sham Comparator: Resection and radiotherapy according to the MRI
Surgical treatment and radiotherapy planned based on MRI+T1C.
Other: MRI+T1C
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: 36 months post surgery
36 months post surgery
Overall survival
Time Frame: 36 months post surgery
36 months post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of tumor volume (GTV) in MRI with contrast in relation to the tumor borders in PET-CT
Time Frame: 1 day before radiotherapy
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.
1 day before radiotherapy
Volumetric assessment of the planned radiotherapy volume based on PET-MRI and MRI planning.
Time Frame: 1 day before radiotherapy
1 day before radiotherapy
Long-term survival rate and prognostic factors (longer than 1 year from diagnosis).
Time Frame: 36 months post surgery
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.
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
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.
7 days post surgery, 1 day before and after radiotherapy
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
The purpose of this analysis is to develop risk factors for recurrence based on postoperative radiological examinations.
36 months post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copernicus Memorial Hospital

Collaborators

Medical Research Agency, Poland

Investigators

  • Principal Investigator: Kamil Krystkiewicz, PhD, Department of Neurosurgery and Neurooncology, Copernicus Memorial Hospital in Łódź, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2025

Primary Completion (Estimated)

August 31, 2030

Study Completion (Estimated)

August 31, 2032

Study Registration Dates

First Submitted

June 2, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/ABM/01/00010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glioblastoma Multiforme

Clinical Trials on MRI+T1C

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe