Measuring Treatment Response in Metastatic Renal Cell Cancer Using FPIA PET/CT (NCT04802824) | Clinical Trial Compass
CompletedNot Applicable
Measuring Treatment Response in Metastatic Renal Cell Cancer Using FPIA PET/CT
United Kingdom10 participantsStarted 2021-05-25
Plain-language summary
Renal cell carcinoma (RCC) is the most prevalent and lethal malignancy of the kidney. At the time of diagnosis, as many as a fifth of patients have metastatic disease (mRCC). Despite advances in treatment, long-term survival rates remain poor. 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 the study is to investigate longitudinal changes in \[18F\]FPIA uptake at baseline, at 4-6 weeks and at 12 weeks following treatment initiation in patients using tyrosine kinase inhibitors (TKI's), chemotherapy, immunotherapy, or combinations of these.
The investigators hypothesise that the import of \[18F\]FPIA-detectable SCFA into tumours is high and decreases with effective treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18
✓. Target metastases size ≥ 1cm (outside of the liver).
✓. The subject has an available diagnostic tumour biopsy of the primary and/or metastatic lesion taken within 3 months of the first \[18F\]FPIA PET/CT.
✓. WHO performance status 0 - 2.
✓. If female, the subject is either post-menopausal (\>1 year), or surgically sterilized (has had a documented bilateral oophorectomy and/or documented hysterectomy, \>2 years), or if of childbearing potential, must have a negative urine pregnancy test at initial screening and/or within 2 hours prior to injection of imaging agent.
✓. eGFR of ≥30 within 3 months of \[18F\]FPIA injection
✓. The subject is able and willing to comply with study procedures, and a signed and dated informed consent is obtained.
✓. The subject is not scheduled to start cancer treatment prior to the first study PET/CT scan.
Exclusion criteria
✕
What they're measuring
1
Quantitative longitudinal measurement of [18F]FPIA uptake in mRCC.
Timeframe: Baseline, 4-6 weeks and 12 weeks post-commencement of treatment.
✕. Evidence of significant medical condition or laboratory finding which, in the opinion of the Investigator, makes it undesirable for the patient to participate in the trial
✕. The subject is receiving or has received 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 scheduled to have a nuclear medicine or contrast scan within 24 hours of the administration of \[18F\]FPIA.
✕. Participants with claustrophobia or who are unable to comfortably tolerate the scanning procedure.