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

Glioblastoma Multiforme of Brain Clinical Trial

— FAM-GBM  

Official title:

An Observational Study to Determine Changes in 18F-fluoropivalate-PET During Postoperative Chemoradiotherapy for Patients With Primary Glioblastoma Multiforme

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05801159
• Other study ID #: 21CX6613
• Status: Recruiting
• Start date: April 19, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: October 2023
• Source: Imperial College London
• Contact: Shah Islam
• Phone: 0203 313 3720
• Email: s.islam[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme of Brain

Intervention

Diagnostic Test:
• Positron Emission Tomography-Computerised Tomography (PET-CT)
Injection of the 18F-fluoropivalate (18F-FPIA) radiotracer followed by a whole brain static PET-CT scan.

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation of [18F]-FPIA uptake with available tumour genetics	[18F]-FPIA SUVmax & SUVmean compared with available tumour genetics.	Through study completion, an average of 4 months
Other	Correlation of [18F]-FPIA with available standard of care MRI variables	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
Primary	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	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.	Baseline PET/CT scan (~1-4 weeks post-surgical resection)
Secondary	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.	Through study completion, an average of 4 months