Measuring Fatty Acid Oxidation in Cerebral Metastases Using [18F]FPIA

NCT ID: NCT04807582

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-25
• Study Completion Date: 2024-03-01

Brief Summary

Cerebral metastases represent a significant problem for oncological management. It is estimated that 20-40% of patients with cancer will develop metastatic cancer to the brain during the course of their illness. 18F-fluoropivalate ([18F]FPIA) is a new tracer that images short chain fatty acid (SCFA) uptake in tumours, a key component of fatty acid oxidation.

The aim of this study is to quantify the degree of early step fatty acid oxidation in cerebral metastases as imaged by [18F]FPIA Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MRI).

The investigators hypothesise that FPIA uptake will be higher in metastases that are treatment naïve compared to those that have undergone treatment, in keeping with viable tumour cells having a high propensity to generate ATP and NADPH via fatty acid oxidation under bioenergetic stress.

Detailed Description

24 evaluable patients with radiological evidence of cerebral metastases on MRI will be enrolled into the study (12 who are treatment naïve + 12 who have completed Stereotactic Radiosurgery (SRS)+/- combination therapy). The patients invited to participate in the study will provide written informed consent. [18F]FPIA PET/MRI imaging will only be performed once patients have satisfied the inclusion and exclusion criteria. Once these have been satisfied, eligible patients will proceed to [18F]FPIA PET/MRI.

On the day of imaging the patients will undergo a blood test to measure plasma concentrations of carnitine (approximately 6mls). During the scan, a single dose of [18F]FPIA (maximum, 370 MBq) IV will be administered to the participant followed by a whole brain dynamic PET/MRI scan over 66 minutes. During the MRI sequences, the patient will receive a 2 stage IV bolus of Gadolinium contrast medium administered through a peripheral venous cannula.

Conditions

Cerebral Metastases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients With Radiological Evidence of IMD That Are Treatment Naive.

Participants with radiological evidence of intracranial metastatic disease (IMD) on standard of care contrast-enhanced magnetic resonance imaging (CE-MRI) that were treatment-naive at the time of enrolment/[18F]FPIA PET-mpMRI scanning.

Participants enrolled into the study had [18F]FPIA positron emission tomography-multiparametric magnetic resonance imaging (PET-mMRI) scan(s) performed at the Invicro, Centre for Imaging Sciences. A single intravenous dose of [18F]FPIA (maximum, 370MBq) was administered to the participant followed by a whole brain dynamic PET-MRI scan over 66 minutes.

[18F]FPIA PET/MRI

Intervention Type: OTHER

18F-fluoropivalate tracer injection followed by PET/MRI scan

Patients With Radiological Evidence of IMD That Had Completed Stereotactic Radiosurgery.

Participants with radiological evidence of intracranial metastatic disease (IMD) on standard of care contrast-enhanced magnetic resonance imaging (CE-MRI) that had completed stereotactic radiosurgery (SRS) (+/- combination therapy) within 4-8 weeks of [18F]FPIA PET-mMRI.

Participants enrolled into the study had [18F]FPIA positron emission tomography-multiparametric magnetic resonance imaging (PET-mMRI) scans performed at the Invicro, Centre for Imaging Sciences. A single intravenous dose of [18F]FPIA (maximum, 370MBq) was administered to the participant followed by a whole brain dynamic PET-MRI scan over 66 minutes.

[18F]FPIA PET/MRI

Intervention Type: OTHER

18F-fluoropivalate tracer injection followed by PET/MRI scan

Interventions

[18F]FPIA PET/MRI

18F-fluoropivalate tracer injection followed by PET/MRI scan

Intervention Type: OTHER

Other Intervention Names

Imaging Scan

Eligibility Criteria

Inclusion Criteria

A) Treatment naïve

or

B) SRS+/- combination treated - Patients that have completed the SRS part of a combination regime enabling a 4-8 week post-SRS treatment PET/MRI scan.

and

C) That fulfil the following criteria:

1. Age ≥18.

2. Target metastases size ≥ 1cm.

3. WHO performance status 0 - 2.

4. 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 prior to tracer administration.

5. The subject is able and willing to comply with study procedures, and signed and dated informed consent is obtained.

6. The subject has a satisfactory medical history as judged by the investigator with no significant co-morbidities.

7. The subject's clinical and laboratory tests are within normal limits and/or considered clinically insignificant.

Exclusion Criteria

1. The subject is pregnant or lactating.

2. Any other chronic illness that will or musculoskeletal condition that would not allow comfortable performance of a PET study.

3. Prior use within 14 days of enrolment or concurrent therapy with any other investigational agent.

4. Unsatisfactory renal function (eGFR<30).

5. The subject has non-MRI compatible devices (e.g.a pacemaker, an implantable cardioverter-defibrillator (ICD), a nerve stimulator, a cochlear implant or a drug pump) or implanted material (e.g. non-MRI compatible sternal wires, biostimulators, metals or alloys).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Imperial College Healthcare NHS Trust

London, , United Kingdom

Countries

United Kingdom

References

Islam S, Inglese M, Aravind P, Barwick TD, Mauri F, McLeavy L, Arstad E, Wang J, Puccio I, Hung L, Lu H, O'Neill K, Waldman AD, Williams M, Aboagye EO. A hybrid [18F]fluoropivalate PET-multiparametric MRI to detect and characterise brain tumour metastases based on a permissive environment for monocarboxylate transport. Eur J Nucl Med Mol Imaging. 2025 Jun;52(7):2290-2306. doi: 10.1007/s00259-025-07118-0. Epub 2025 Feb 7.

Reference Type: DERIVED

PMID: 39915301 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

19CX5551

Identifier Type: -

Identifier Source: org_study_id