Measuring Fatty Acid Oxidation in Gliomas Using 18F-FPIA PET/MRI
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04097535|
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : May 27, 2020
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.
|Condition or disease||Intervention/treatment|
10 evaluable participants with suspected cerebral glioma on previous MRI who are due to undergo surgical resection or biopsy will be enrolled into the study. The patients invited to participate in the study will provide full consent, but will only undergo 18F-FPIA PET/MRI imaging once they have satisfied the inclusion and exclusion criteria. Once these have been satisfied, eligible participants will proceed to 18F-FPIA PET/MRI.
On the day of imaging the participants will undergo a blood test to measure plasma concentrations of carnitine. 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 participant will receive an additional IV bolus of Gadolinium contrast medium administered through a peripheral venous cannula. Arterial blood sampling through a peripheral arterial line will be performed to determine the concentration of radiotracer within arterial plasma. All the participants that are enrolled into the study will undergo biopsy or surgical resection as part of their routine clinical care, from which their tumour grade will be confirmed; the Investigators will obtain tissue from these procedures to perform metabolomics, genomics and proteomics. Surgery or biopsy will be performed typically within 2 weeks but no later than 3 months.
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||Determining the Magnitude of Early Steps of Fatty Acid Oxidation in Glioma Using 18F-FPIA|
|Actual Study Start Date :||December 6, 2018|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||November 1, 2020|
- Other: PET/MRI
- Quantitative measurement of 18F-FPIA uptake in human gliomas [ Time Frame: Through study completion, an average of 1 year ]PET/MRI
- Correlation of 18F-FPIA uptake with tumour type and histological grade including O6-methylguanine-DNA methyltransferase (MGMT) and isocitrate dehydrogenase (IDH) gene expression. [ Time Frame: Through study completion, an average of 1 year ]PET/MRI & IHC
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097535
|Contact: Shah Islam, MBBS FRCR||0203 313 1000 ext email@example.com|
|Contact: CCIC||0203 313 1000 ext firstname.lastname@example.org|
|Imperial College Healthcare NHS Trust/ Imperial College london||Recruiting|
|London, United Kingdom, W12 0NN|
|Contact: Shah Islam, MBBS, FRCR 02033133720|
|Contact: CCIC 02033133720 email@example.com|
|Principal Investigator: Matthew Williams, MBChB|
|Sub-Investigator: Shah Islam, MBBS FRCR|
|Principal Investigator:||Matthew Williams, MBChB||Imperial College Healthcare NHS Trust|