The study will be a phase 2, open-label study in patients with solid tumours to explore the relationship between short-chain fatty acid uptake using \[18F\]FPIA PET/CT and tumour proliferation
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
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
21
\[18F\]FPIA radiotracer administration
PET/CT scan
Guy's & St. Thomas' NHS Foundation Trust
London, United Kingdom
RECRUITINGImperial College Healthcare NHS Trust
London, United Kingdom
RECRUITINGThe Royal Marsden NHS Foundation Trust
London, United Kingdom
NOT_YET_RECRUITINGThe relationship between [18F]FPIA uptake and percent positive tumour cells reported as counts defined per area from whole section immunohistochemistry for PHH3.
To explore the relationship between short-chain fatty acid uptake using \[18F\]FPIA PET/CT and tumour proliferation in patients with solid tumours.
Time frame: 6 months
Estimation of SUVmax of target lesions at 30 minutes and 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.
Time frame: 60 min
Estimation of tumour-to-background ratio of target lesions at 30 minutes and 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.
Time frame: 60 min
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.
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).
Time frame: 15 days
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.
To explore the relationship between \[18F\]FPIA PET/CT and other known tumour proliferation markers
Time frame: 6 months
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