N/A
N=22
Measuring Fatty Acid Oxidation in Cerebral Metastases Using [18F]FPIA
Cerebral Metastases
Bottom Line
View on ClinicalTrials.gov: NCT04807582 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Quantitative Measurement of [18F]FPIA Uptake Within the Cerebral Metastases of Treatment naïve Patients. — 1.54; 1.47; 1.48 SUV_max (kBq/L/kBq/g)
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- [18F]FPIA PET/MRI (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quantitative Measurement of [18F]FPIA Uptake Within the Cerebral Metastases of Treatment naïve Patients. |
1.54; 1.47; 1.48 | — |
| PRIMARY Quantitative Measurement of [18F]FPIA Uptake Within the Cerebral Metastases of Patients Treated With Stereotactic Radiosurgery (SRS). |
1.45; 1.15; 1.17 | — |
| SECONDARY Distribution of [18F]FPIA Uptake in Lesions Which Have Undergone Treatment, With Those That Are Treatment naïve. |
3.75; 3.97; 3.71; 3.85; 3.73; 3.90 | — |
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 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:
- 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.
Exclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT04807582). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.