Clinical trial · Interventional
FET-PET Directed Simultaneous In-field Boost for Primary GBM
Safety and Preliminary Efficacy of Hipofractionated Irradiation Based on Dual FET-PET in Patients With Primary Glioblastoma Multiforme With Concomitant Temozolomide
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The combination of anatomical MRI examination with functional examination of tissue metabolic activity such as FET-PET (PET using the radiotracer - 18F-fluoro-ethyl-tyrosine) is a valuable tool to determine the actual tumor infiltration. The FET-PET examination can be performed using the dual-time point aqusition of FET for exact treatment planning. It has also been proven that using the dual FET-PET method, it is possible to obtain a precise image of the glioblastoma infiltration corresponding to the location and shape of the recurrence, and the tumor volumes in dual FET-PET are significantly larger than in MRI. Moreover, tumor defined in dual FET-PET is different than that of the tumor defined in single FET-PET acquisition. In the DualFETboosT trial we plan to assess the safety and preliminary efficacy of hypofractionated irraditon using simultaneous in-field boost directed on dual FET-PET based tumor volumes for treatment of primary glioblastoma multiforme with concomitant temozolomide.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Moderately Hypofractionated Radiotherapy using Simultaneous In-Field Boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Simultaneous In-Field Boost on FET-PET positive target volumes
- interventionNames
- Radiation: Moderately Hypofractionated Radiotherapy using Simultaneous In-Field Boost
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- assessed up to 24 months
- description
- From date of surgery until the date of death from any cause, percent of patient that are alive 1 and 2 years after surgery
Secondary outcomes (5)
- measure
- Progression Free Survival
- timeFrame
- up to 24 months
- description
- from the date of surgery until progression of the disease or the date of death from any cause assessed
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathological confirmation of glioblastoma (WHO grade IV) * Age between 18-75 years of age * General condition according to the Zubrod scale 0 or 2 * The results of the blood counts are normal * Liver enzyme parameters normal * The results of the parameters of the patient's functions are normal * Informed consent to participate in the category Exclusion Criteria: * Coexistence of another cancer * The location of the tumor in the area of the brain stem or cerebellum * Prior brain radiation therapy * No uptake visible in the FET-PET imaging * Contraindications for MRI * Contraindications to radiotherapy or chemotherapy * Pregnancy, lack of consent to the use of protection against pregnancy, puerperium * Alcohol addiction * Mental illness * Claustrophobia
References
Publications (1)
- DERIVEDHarat M, Blok M, Miechowicz I, Wiatrowska I, Makarewicz K, Malkowski B. Safety and Efficacy of Irradiation Boost Based on 18F-FET-PET in Patients with Newly Diagnosed Glioblastoma. Clin Cancer Res. 2022 Jul 15;28(14):3011-3020. doi: 10.1158/1078-0432.CCR-22-0171. PMID 35552391