NCT05801159Completed
[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 · Last updated 9 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 3 (actual)
- First submitted
- 7 Feb 2023
- Start date
- 19 Apr 2022
- Primary completion date
- 2 Apr 2025
- Lead sponsor
- Imperial College London
- Diseases
- Glioblastoma
- NCT number
- NCT05801159
What you commit to
- Study type: Observational
- Participants enrolled: 3
- From 19 Apr 2022 to the primary completion date, 2 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 has received another investigational radioactive tracer within 1 month before administration of 18F-FPIA injection.
Other illness
- Any other chronic illness that will or musculoskeletal condition that would not allow comfortable performance of a static PET study.
Lab values
- Unsatisfactory renal function (epidermal growth factor receptor, eGFR\<60) within 3 months of \[18F\]FPIA injection.
Other
- The subject is pregnant or lactating.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.