Clinical trial · Observational
Measuring Treatment Response in Metastatic Renal Cell Cancer Using FPIA PET/CT
Determining the Magnitude of Change in [18F]FPIA-detectable Short Chain Fatty Acid Uptake in Metastatic Renal Cell Cancer Following Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET/CT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Quantitative longitudinal measurement of [18F]FPIA uptake in mRCC.
- timeFrame
- Baseline, 4-6 weeks and 12 weeks post-commencement of treatment.
- description
- PET/CT
Secondary outcomes (2)
- measure
- Quantitative measurement of FPIA in healthy tissue including kidneys.
- timeFrame
- Baseline, 4-6 weeks and 12 weeks post-commencement of treatment.
- description
- PET/CT
- measure
- Comparison of [18F]FPIA relative to baseline at 4-6 weeks and at 12 weeks (± 4 weeks) to changes on a patient's routine imaging scan.
- timeFrame
- Baseline, 4-6 weeks and 12 weeks post-commencement of treatment.
- description
- Routine Imaging Scans - Determined by the NHS Treating Clinician.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients with radiological and/or histological evidence of evidence of mRCC who are either: A. Treatment naïve or newly relapsed (not currently on treatment) or B. Progressing on standard of care systemic therapy and C. That fulfil the following criteria: 1. Age ≥18 2. Target metastases size ≥ 1cm (outside of the liver). 3. 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. 4. WHO performance status 0 - 2. 5. 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. 6. eGFR of ≥30 within 3 months of \[18F\]FPIA injection 7. The subject is able and willing to comply with study procedures, and a signed and dated informed consent is obtained. 8. The subject is not scheduled to start cancer treatment prior to the first study PET/CT scan. Exclusion Criteria: 1. Pregnant or lactating women 2. 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 3. 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. 4. The subject is scheduled to have a nuclear medicine or contrast scan within 24 hours of the administration of \[18F\]FPIA. 5. Participants with claustrophobia or who are unable to comfortably tolerate the scanning procedure.
References
Publications (0)
Data not yet available