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

NCT04807582 | Completed Results

• 1 other identifier: 19CX5551
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Metastases

Keywords

PET/MRI; Fatty Acid Oxidation

Outcome Measures

Primary Outcomes (2)

• Quantitative Measurement of [18F]FPIA Uptake Within the Cerebral Metastases of Treatment naïve Patients.

  Standardised uptake value (SUV) at 60 minutes post-injection of \[18F\]FPIA assessed using PET/MRI. SUV is a semiquantitative measurement of radiotracer uptake in tissue. It is a ratio of tissue radioactivity concentration at a point in time within a specific region of interest and the injected dose of radioactivity per kilogram of the patient's body weight. SUVmax is the highest SUV value within a region of interest.

  On the scan day up to 60 minutes

• Quantitative Measurement of [18F]FPIA Uptake Within the Cerebral Metastases of Patients Treated With Stereotactic Radiosurgery (SRS).

  Standardised uptake value (SUV) at 60 minutes post-injection of \[18F\]FPIA assessed using PET/MRI. SUV is a semiquantitative measurement of radiotracer uptake in tissue. It is a ratio of tissue radioactivity concentration at a point in time within a specific region of interest and the injected dose of radioactivity per kilogram of the patient's body weight. SUVmax is the highest SUV value within a region of interest.

  On the scan day (4-8 weeks post-SRS treatment)

Secondary Outcomes (1)

• Distribution of [18F]FPIA Uptake in Lesions Which Have Undergone Treatment, With Those That Are Treatment naïve.

  On the scan day (4-8 weeks post-SRS treatment)

Study Arms (2)

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.

Other: [18F]FPIA PET/MRI

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.

Other: [18F]FPIA PET/MRI

Interventions

[18F]FPIA PET/MRI OTHER

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

Also known as: Imaging Scan

Patients With Radiological Evidence of IMD That Are Treatment Naive.; Patients With Radiological Evidence of IMD That Had Completed Stereotactic Radiosurgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with radiological evidence of cerebral metastases on MRI that are either treatment naïve or have been treated with SRS +/- combination therapy within 4-8 weeks.

You may qualify if:

• A) Treatment naïve
• 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:
• Age ≥18.
• Target metastases size ≥ 1cm.
• 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 prior to tracer administration.
• 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.
• The subject's clinical and laboratory tests are within normal limits and/or considered clinically insignificant.

You may not qualify if:

• The subject is pregnant or lactating.
• Any other chronic illness that will or musculoskeletal condition that would not allow comfortable performance of a PET study.
• Prior use within 14 days of enrolment or concurrent therapy with any other investigational agent.
• Unsatisfactory renal function (eGFR\<30).
• 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).

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39915301 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample taken for carnitine analysis.

Results Point of Contact

• Title: Professor Eric Aboagye
• Organization: Imperial College London

eric.aboagye@imperial.ac.uk

0203 313 3720

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 19, 2021
• Study Start: September 25, 2020
• Primary Completion: June 30, 2023
• Study Completion: March 1, 2024
• Last Updated: April 2, 2025
• Results First Posted: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)