Clinical trial · Observational
[18F]FPIA PET-CT in Glioblastoma Multiforme (GBM)
An Observational Study to Determine Changes in 18F-fluoropivalate-PET During Postoperative Chemoradiotherapy for Patients With Primary Glioblastoma Multiforme
- 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)
Glioma is the most common primary malignant brain tumour in adults and has an extremely poor prognosis. Glioblastoma is the most common subtype and its most aggressive form, with an annual incidence of 3.19 cases per 100,000. The aim of this study is to quantify the degree of fatty acid oxidation in 20 participants diagnosed with glioblastoma multiforme (GBM) that have undergone surgical resection throughout the course of their chemotherapy and radiotherapy treatment. The investigators hypothesise that the parameters derived from longitudinal 18F-fluoropivalate (18F-FPIA) positron emission tomography (PET) will change predictably over the course of therapy in relation to response.
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 of Brain | Brain Glioblastoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Positron Emission Tomography-Computerised Tomography (PET-CT) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Impact of CRT on [18F]-FPIA-detectable fatty acid metabolism
- timeFrame
- Through study completion, an average of 4 months
- description
- Change in the \[18F\]FPIA maximum standardised uptake value (SUVmax) \& average standardised uptake value (SUVmean) from baseline through the post-treatment PET/CT scan.
Secondary outcomes (2)
- measure
- Detection of post-operative residual disease
- timeFrame
- Baseline PET/CT scan (~1-4 weeks post-surgical resection)
- description
- \[18F\]FPIA SUVmax \& SUVmean at baseline compared to the MRI variables (standardised uptake value (SUV) and lesion-to-grey matter ration \[l/g\]) measured post-operatively as per standard of care.
- measure
- CRT response assessment using [18F]-FPIA PET
- timeFrame
- Through study completion, an average of 4 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients with histologically confirmed GBM following surgical resection of their tumour and are eligible for adjuvant chemoradiation with the following characteristics will be recruited: * Age ≥18 * World Health Organisation (WHO) performance status 0 - 2. * If female, the subject is either post-menopausal (at least 1 year), or surgically sterilized (has had a documented bilateral oophorectomy and/or documented hysterectomy for at least 2 years), or if of childbearing potential, must have a negative urine beta human chorionic gonadotropin (beta-HCG) pregnancy test done at initial screening and on the day of tracer administration. The result of the pregnancy test must be known before administration of 18F-FPIA injection. * The subject is able and willing to comply with study procedures, and signed and dated informed consent is obtained. * The subject has a satisfactory medical history as judged by the investigator with no significant co-morbidities, physical examination, and vital signs findings during the screening period (from 21 days before administration). * The subject's clinical and laboratory tests are within normal limits and/or considered clinically insignificant. Exclusion Criteria: * The subject has received any chemotherapy, immunotherapy, biologic therapy or investigational therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of 18F-FPIA injection. * The subject is pregnant or lactating. * Any other chronic illness that will or musculoskeletal condition that would not allow comfortable performance of a static PET study. * The subject has received another investigational radioactive tracer within 1 month before administration of 18F-FPIA injection. * Unsatisfactory renal function (epidermal growth factor receptor, eGFR\<60) within 3 months of \[18F\]FPIA injection.
References
Publications (0)
Data not yet available