Measuring Treatment Response in Metastatic Renal Cell Cancer Using FPIA PET/CT

NCT04802824 | Completed

• 1 other identifier: 20CX6143
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Renal Cell Carcinoma

Keywords

PET/CT; Fatty Acid Oxidation

Outcome Measures

Primary Outcomes (1)

• Quantitative longitudinal measurement of [18F]FPIA uptake in mRCC.

  PET/CT

  Baseline, 4-6 weeks and 12 weeks post-commencement of treatment.

Secondary Outcomes (2)

• Quantitative measurement of FPIA in healthy tissue including kidneys.

  Baseline, 4-6 weeks and 12 weeks post-commencement of treatment.

• 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.

  Baseline, 4-6 weeks and 12 weeks post-commencement of treatment.

Other Outcomes (2)

• [18F]FPIA uptake versus Foundation Medicine mutational signature test (Tumour Mutational Burden (TMB)) on biopsy material.

  Through study completion, an average of 3 years.

• [18F]FPIA uptake versus serum or urine carnitine/carnitine ester signature.

  Through study completion, an average of 3 years.

Interventions

PET/CT OTHER

18F-fluoropivalate PET/CT scan.

Also known as: Imaging Scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with radiological and/or histological evidence of mRCC and due to receive systemic therapy.

You may qualify if:

• Patients with radiological and/or histological evidence of evidence of mRCC who are either:
• A. Treatment naïve or newly relapsed (not currently on treatment)
• B. Progressing on standard of care systemic therapy
• and
• C. That fulfil the following 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Healthcare NHS Trust/Imperial College London

London, W12 0HS, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Archival tumour biopsies from the primary or metastatic lesion, taken within 3 months of the first \[18F\]FPIA PET/CT scan.

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 17, 2021
• Study Start: May 25, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)