Status:
COMPLETED
Measuring Treatment Response in Metastatic Renal Cell Cancer Using FPIA PET/CT
Lead Sponsor:
Imperial College London
Conditions:
Metastatic Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
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 treat...
Detailed 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...
Eligibility Criteria
Inclusion
- 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:
- 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
- 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.
Key Trial Info
Start Date :
May 25 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04802824
Start Date
May 25 2021
End Date
June 30 2023
Last Update
May 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Imperial College Healthcare NHS Trust/Imperial College London
London, United Kingdom, W12 0HS