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

Last updated: March 13, 2025
Sponsor: Imperial College London
Overall Status: Completed

Phase

N/A

Condition

Neoplasm Metastasis

Brain Metastases

Treatment

[18F]FPIA PET/MRI

Clinical Study ID

NCT04807582
19CX5551
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 surgicallysterilized (has had a documented bilateral oophorectomy and/or documentedhysterectomy for at least 2 years), or if of childbearing potential, must have anegative urine beta human chorionic gonadotropin (beta-hCG) pregnancy test doneprior to tracer administration.

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

  6. The subject has a satisfactory medical history as judged by the investigator with nosignificant co-morbidities.

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

Exclusion

Exclusion Criteria:

  1. The subject is pregnant or lactating.

  2. Any other chronic illness that will or musculoskeletal condition that would notallow comfortable performance of a PET study.

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

  4. Unsatisfactory renal function (eGFR<30).

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

Study Design

Total Participants: 22
Treatment Group(s): 1
Primary Treatment: [18F]FPIA PET/MRI
Phase:
Study Start date:
September 25, 2020
Estimated Completion Date:
March 01, 2024

Study 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.

Connect with a study center

  • Imperial College Healthcare NHS Trust

    London, W12 0HS
    United Kingdom

    Site Not Available

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