[18F]FPIA PET/CT Imaging in Patients With Solid Tumours ([18F]FPIA)
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|ClinicalTrials.gov Identifier: NCT04717674|
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : March 17, 2022
|Condition or disease||Intervention/treatment||Phase|
|Cancer Tumor, Solid||Drug: [18F]Fluoropivalate ([18F]Fluoro-2,2-Dimethylpropionic Acid) Procedure: PET/CT||Phase 2|
Cancers have increased energy demands to allow for their rapid growth compared to healthy cells. Glucose is the main source of energy for many cells in the body, and clinicians routinely use a scan which looks at glucose metabolism to assess if cancer treatment is working. However, some cancer cells can create energy to survive and grow in a different way, using fatty acids. In this study, the investigators are using a PET/CT scan to look at a variety of cancer types to see which cancers use fatty acids for energy and if this can be measured. The PET/CT scan will be carried out twice on 2 separate visits so that the investigators can check that both scans give the same result.
The investigators will also carry out special tests on the tumour tissue taken during routine cancer surgery. These tests will look for specific substances in the cancer cells that are related to cancer biology and growth. The investigators will then compare the results from the surgical tissue to the results of the scan to see if there is a relationship between them.
The study will look at 21 patients with solid tumours conducted in 4 NCITA accredited centres, which have different strengths in recruiting specific patient/tumour-type cohorts. Each patient will have two scan visits (between 2-15 days apart) prior to any new treatment starting to check that the scan measurements are repeatable.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Investigation of Short-chain Fatty Acid Uptake in Solid Tumours as Assessed by [18F]Fluoropivalate Positron Emission Tomography and Its Relationship With Tumour Proliferation|
|Actual Study Start Date :||December 7, 2021|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||October 2023|
Experimental: Drug: [18F]Fluoropivalate ([18F]Fluoro-2,2-Dimethylpropionic Acid) (FPIA)
Participants will undergo two PET/CT scans with the tracer [18F]Fluoropivalate ([18F]Fluoro-2,2-Dimethylpropionic Acid) (FPIA), referred to as [18F]FPIA, on 2 separate visits.
Drug: [18F]Fluoropivalate ([18F]Fluoro-2,2-Dimethylpropionic Acid)
[18F]FPIA radiotracer administration
Other Name: None are used.
- The relationship between [18F]FPIA uptake and percent positive tumour cells reported as counts defined per area from whole section immunohistochemistry for PHH3. [ Time Frame: 6 months ]To explore the relationship between short-chain fatty acid uptake using [18F]FPIA PET/CT and tumour proliferation in patients with solid tumours.
- Estimation of SUVmax of target lesions at 30 minutes and 60 min. [ Time Frame: 60 min ]The SUVmax of the target lesions will be estimated for both timepoints (i.e. 30 min and 60 min) in order to assess changes in this measurand at the two time points.
- Estimation of tumour-to-background ratio of target lesions at 30 minutes and 60 min. [ Time Frame: 60 min ]The tumour-to-background ratio of the target lesions will be estimated for both timepoints (i.e. 30 min and 60 min), in order to assess changes in this measurand at the two time points.
- Graphical presentation and reliability of repeat semi-quantitative measure (SUV) of target lesions between two PET scans for each time point (30 min and 60 min). Bland Altman and ICC will be presented. [ Time Frame: 15 days ]To assess the repeatability of the two [18F]FPIA PET scans, as this can impact the primary end point. The two [18F]FPIA PET scans will be 2-15 days apart, and each will consist of two imaging timepoints (30 minutes and 60 minutes).
- Graphical presentation of [18F]FPIA uptake and whole section immunohistochemistry for Ki-67 and mitotic count (mitoses per mm2) assessed on hematoxylin and eosin (H&E) sections. Pearson's correlation coefficient will be reported. [ Time Frame: 6 months ]To explore the relationship between [18F]FPIA PET/CT and other known tumour proliferation markers
- To explore the relationship between [18F]FPIA tumour uptake and histological markers of tumour metabolism. [ Time Frame: 6 months ]Graphical and tabular description of the relationship of [18F]FPIA uptake with biological markers including pan-mitochondrial markers (succinate dehydrogenase [SDHA], citrate synthase), and fatty acid oxidation enzymes (carnitine palmitoyltransferase I/carnitine acyltransferase I [CPT1/CAT1], carnitine-acylcarnitine translocase [CACT], SLC22A2, SLC22A5, and SLC25A20), evaluated by IHC
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): NCT04717674
|Contact: Laura McLeavy||0203 313 firstname.lastname@example.org|
|Contact: Tara Barwickemail@example.com|
|Guy's & St. Thomas' NHS Foundation Trust||Recruiting|
|London, United Kingdom|
|Contact: Gary Cook|
|Imperial College Healthcare NHS Trust||Recruiting|
|London, United Kingdom|
|Contact: Tara Barwick|
|The Royal Marsden NHS Foundation Trust||Not yet recruiting|
|London, United Kingdom|
|Contact: Siraj Yusuf|
|Principal Investigator:||Tara Barwick||University College, London|