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

NCT05801159 | Completed

• 1 other identifier: 21CX6613
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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. 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

Glioblastoma Multiforme of Brain

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, an average of 4 months

Secondary Outcomes (2)

• Detection of post-operative residual disease

  Baseline PET/CT scan (~1-4 weeks post-surgical resection)

• CRT response assessment using [18F]-FPIA PET

  Through study completion, an average of 4 months

Other Outcomes (2)

• Correlation of [18F]-FPIA uptake with available tumour genetics

  Through study completion, an average of 4 months

• Correlation of [18F]-FPIA with available standard of care MRI variables

  Through study completion, an average of 4 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

The participant will undergo a blood test to measure plasma concentrations of carnitine.

MeSH Terms

Interventions

Positron Emission Tomography Computed Tomography

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Matthew Williams

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: April 6, 2023
• Study Start: April 19, 2022
• Primary Completion: April 2, 2025
• Study Completion: April 2, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

GB (1)