Glioblastoma Multiforme of BrainFAM-GBMNCT05801159
[18F]FPIA PET-CT in Glioblastoma Multiforme (GBM)
An observational study of Glioblastoma Multiforme of Brain, run by Imperial College London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme of Brain
- What is being tested?
- Positron Emission Tomography-Computerised Tomography (PET-CT)
- Type of treatment
- Injection or infusion
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Apr 2022to 2 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with histologically confirmed GBM following surgical resection of their tumour and are eligible for adjuvant chemoradiation.
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study to Determine Changes in 18F-fluoropivalate-PET During Postoperative Chemoradiotherapy for Patients With Primary Glioblastoma Multiforme
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.
Read the detailed description
Twenty evaluable participants with histologically confirmed glioblastoma multiforme (GBM) following surgical resection that are due to undergo treatment with chemoradiotherapy (CRT) will be enrolled into the study. The patients invited to participate in the study will provide written informed consent, but will only undergo 18F-FPIA positron emission tomography-computerised tomography (PET-CT) imaging once they have satisfied the inclusion and exclusion criteria. Once these criteria have been satisfied, eligible participants will proceed with a 18F-FPIA PET-CT post-surgical resection/prior to CRT, mid-therapy (~4-6 weeks from the start of CRT, and at the end of CRT treatment (~10-14 weeks from the end of treatment).
All the participants that are enrolled in the study will have undergone surgical resection as part of their routine clinical care from which a tissue diagnosis will be confirmed.
On the scan date, the participants will undergo a blood test to measure plasma concentrations of carnitine. During the scan, a single dose of 18F-FPIA (maximum, 370MBq) intravenous (IV) will be administered to the participant followed by a whole brain static PET-CT scan 40 minutes post-injection.
- Conditions
- Glioblastoma Multiforme of Brain
- Being tested
- Positron Emission Tomography-Computerised Tomography (PET-CT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron Emission Tomography-Computerised Tomography (PET-CT)Diagnostic test
Injection of the 18F-fluoropivalate (18F-FPIA) radiotracer followed by a whole brain static PET-CT scan.
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of CRT on [18F]-FPIA-detectable fatty acid metabolism
Change in the [18F]FPIA maximum standardised uptake value (SUVmax) \& average standardised uptake value (SUVmean) from baseline through the post-treatment PET/CT scan.
Measured: Through study completion, an average of 4 months
Secondary outcomes (2)
Detection of post-operative residual disease
[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.
Measured: Baseline PET/CT scan (~1-4 weeks post-surgical resection)
CRT response assessment using [18F]-FPIA PET
Change in [18F]FPIA SUVmax \& SUVmean in patients who ultimately show progressive disease/stable disease/partial response on standard of care imaging.
Measured: Through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start19 Apr 2022
- Primary completion2 Apr 2025
- Study completion2 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma Multiforme of BrainStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Williams, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801159
- Sponsor's protocol ID
- 21CX6613
- Acronym
- FAM-GBM
- Status last verified
- Apr 2025
- First submitted
- 7 Feb 2023
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Determine Changes in 18F-fluoropivalate-PET During Postoperative Chemoradiotherapy for Patients With Primary Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT05801159
- Acronym / sponsor ID
- FAM-GBM / 21CX6613
- Conditions
- Glioblastoma Multiforme of Brain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 2 Apr 2025 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Twenty evaluable participants with histologically confirmed glioblastoma multiforme (GBM) following surgical resection that are due to undergo treatment with chemoradiotherapy (CRT) will be enrolled into the study. The patients invited to participate in the study will provide written informed consent, but will only undergo 18F-FPIA positron emission tomography-computerised tomography (PET-CT) imaging once they have satisfied the inclusion and exclusion criteria. Once these criteria have been satisfied, eligible participants will proceed with a 18F-FPIA PET-CT post-surgical resection/prior to CRT, mid-therapy (~4-6 weeks from the start of CRT, and at the end of CRT treatment (~10-14 weeks from the end of treatment).
All the participants that are enrolled in the study will have undergone surgical resection as part of their routine clinical care from which a tissue diagnosis will be confirmed.
On the scan date, the participants will undergo a blood test to measure plasma concentrations of carnitine. During the scan, a single dose of 18F-FPIA (maximum, 370MBq) intravenous (IV) will be administered to the participant followed by a whole brain static PET-CT scan 40 minutes post-injection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically confirmed GBM following surgical resection of their tumour and are eligible for adjuvant chemoradiation.
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positron Emission Tomography-Computerised Tomography (PET-CT)Injection of the 18F-fluoropivalate (18F-FPIA) radiotracer followed by a whole brain static PET-CT scan. | Diagnostic test | – |
Primary outcome
Impact of CRT on [18F]-FPIA-detectable fatty acid metabolism
Time frame: Through study completion, an average of 4 months
Change in the [18F]FPIA maximum standardised uptake value (SUVmax) \& average standardised uptake value (SUVmean) from baseline through the post-treatment PET/CT scan.
2 secondary outcomes
Detection of post-operative residual disease
Time frame: Baseline PET/CT scan (~1-4 weeks post-surgical resection)
CRT response assessment using [18F]-FPIA PET
Time frame: Through study completion, an average of 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Williams principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma Multiforme of Brain, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of CRT on [18F]-FPIA-detectable fatty acid metabolism (time frame: Through study completion, an average of 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.