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

Metastatic Renal Cell Carcinoma Clinical Trial

Official title: Determining the Magnitude of Change in [18F]FPIA-detectable Short Chain Fatty Acid Uptake in Metastatic Renal Cell Cancer Following Therapy

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

24 evaluable patients with radiological and/or histological evidence of mRCC and due to receive systemic therapy will be enrolled. The patients invited to participate in the study will provide written informed consent. Patients will only undergo [18F]FPIA positron emission tomography (PET)/computed tomography (CT) imaging once they have satisfied the inclusion and exclusion criteria. Once these have been satisfied, eligible patients will proceed to [18F]FPIA PET/CT. Patients will have three imaging visits at baseline, 4-6 weeks and 12 weeks post the commencement of treatment. Patients will have been treated as per standard of care, which may have included TKI's, chemotherapy, immunotherapy or combinations of these. Data will be considered complete when patients have all three analysable scans. In the event of dropout, additional subjects will be recruited to reach a total number of 24 evaluable subjects.

On each day of imaging the patients will have a blood test and a urine sample collected to measure concentrations of carnitine. For each scan, a single dose of [18F]FPIA (maximum 370 MBq) IV will be administered to the participant. The participant will then rest in a quiet place for an uptake period and undergo whole body PET/CT scanning from 60 minutes.

Archival tumour biopsies (primary or metastatic lesion), taken within 3 months of the 1st [18F]FPIA PET/CT scan will be retrieved for analysis where possible. ;

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma

• NCT number: NCT04802824
• Study type: Observational
• Source: Imperial College London
• Contact: Preetha Aravind, MBBS MD MRCP
• Phone: 0203 313 3720
• Email: preetha.aravind@nhs.net
• Status: Recruiting
• Start date: May 25, 2021
• Completion date: August 2024