N/A
N=11
Measuring Fatty Acid Oxidation in Gliomas Using 18F-FPIA PET/MRI
Glioma
Bottom Line
View on ClinicalTrials.gov: NCT04097535 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Quantitative Measurement of [18F]-FPIA Uptake in Human Gliomas — 0.9041; 1.3529; 2.0470 SUV60_max
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- PET/MRI (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quantitative Measurement of [18F]-FPIA Uptake in Human Gliomas |
0.9041; 1.3529; 2.0470 | — |
| SECONDARY Correlation of 18F-FPIA Uptake With Tumour Type and Histological Grade Including O6-methylguanine-DNA Methyltransferase (MGMT) and Isocitrate Dehydrogenase (IDH) Gene Expression. |
2; 3; 0; 0; 0; 5 | — |
Summary
Glioma is the most common primary malignant brain tumour in adults and has an extremely poor prognosis. The aim of this study is to quantify the degree of early step fatty acid oxidation in gliomas as imaged by 18F-FPIA PET/MRI in 10 evaluable patients.
The Investigators hypothesise that FPIA uptake will be higher in high-grade gliomas compared to lower grade gliomas, in keeping with a higher propensity of high grade tumours to generate ATP and NADPH via fatty acid oxidation under bioenergetic stress.
Eligibility Criteria
Inclusion Criteria
Patients with radiological evidence of suspected cerebral glioma due for surgery or biopsy and with the following characteristics will be recruited:
- Age ≥18
- Tumour size at least 2 cm.
- 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 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
- 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.
- The subject is diabetic or has uncontrolled blood glucose or blood lipid levels (clinical decision by investigator), any other chronic illness that will preclude brief discontinuation of medication, or musculoskeletal condition that would not allow comfortable performance of a 66-minute study.
- The subject has received another investigational radioactive tracer within 1 month before administration of 18F-FPIA injection.
- Anticoagulation therapy, prolonged prothrombin time, abnormal Allen's test.
- Unsatisfactory renal function (eGFR<60)
Data sourced from ClinicalTrials.gov (NCT04097535). 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.