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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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
. Pregnant or lactating women
. 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.