[18F]FPIA PET-CT in Glioblastoma Multiforme (GBM) (FAM-GBM)

October 3, 2023 updated by: Imperial College London

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

20

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with histologically confirmed GBM following surgical resection of their tumour and are eligible for adjuvant chemoradiation.

Description

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of post-operative residual disease
Time Frame: Baseline PET/CT scan (~1-4 weeks post-surgical resection)
[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.
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
Change in [18F]FPIA SUVmax & SUVmean in patients who ultimately show progressive disease/stable disease/partial response on standard of care imaging.
Through study completion, an average of 4 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of [18F]-FPIA uptake with available tumour genetics
Time Frame: Through study completion, an average of 4 months
[18F]-FPIA SUVmax & SUVmean compared with available tumour genetics.
Through study completion, an average of 4 months
Correlation of [18F]-FPIA with available standard of care MRI variables
Time Frame: Through study completion, an average of 4 months
Change in [18F]-FPIA SUVmax & SUVmean compared with available standard of care MRI variables (standardised uptake value (SUV) and lesion-to-grey matter ration [l/g]).
Through study completion, an average of 4 months

Collaborators and Investigators

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

Sponsor

Imperial College London

Investigators

  • Principal Investigator: Matthew Williams, Imperial College Healthcare NHS Trust

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)

April 19, 2022

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

February 7, 2023

First Submitted That Met QC Criteria

March 23, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21CX6613

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.

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