Piflufolastat F 18 PET/CT in Patients With Suspected, or at High Risk for Metastatic ccRCC (NCT07084909) | Clinical Trial Compass
WithdrawnPhase 2/3
Piflufolastat F 18 PET/CT in Patients With Suspected, or at High Risk for Metastatic ccRCC
Stopped: Operational challenges in patient enrollment
United States0Started 2025-11
Plain-language summary
This study is being conducted to test whether an imaging technique called a "piflufolastat F 18 PET/CT" imaging scan can be used to diagnose and describe the extent of clear cell Renal Carcinoma in patients.
The main questions it aims to answer are:
* What is the most appropriate dose and scan timing window for piflufolastat F 18 PET/CT for patients with clear cell Renal Cell Carcinoma (ccRCC) with known metastatic disease?
* Ability of piflufolastat F 18 PET/CT to detect metastatic of lesions ccRCC in patients with suspected metastatic disease and those at high risk for metastatic disease (the cancer has spread beyond the kidney) and impact of the imaging on clinical management of the kidney cancer?
Participants will:
* Receive a single injection of piflufolastat F 18 injection followed by imaging scans.
* Be contacted via telephone to ask about any reactions or discomforts they may have after the piflufolastat F 18 injection.
* May be followed for up to 6 months to collect data about disease progression.
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
. Male and female patients ≥18 years of age
. Patients must have the ability to understand and sign an approved informed consent form (ICF)
. Patients must have the ability to understand and comply with all protocol requirements.
. Subjects should satisfy the following criteria:
. Newly diagnosed ccRCC patients or post- nephrectomy/post-partial nephrectomy patients with radiographically suspected ccRCC metastatic disease by conventional imaging (CI) planned for biopsy to confirm metastatic disease
. T2B-T4, N0, M0 as assessed by conventional imaging (CI) at initial staging pre-nephrectomy/pre-partial nephrectomy
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
Phase 2 Primary Objective - Establishing the optimum dose and timing window of piflufolastat F18 for detection of metastatic disease
Timeframe: On Day 1 (day of injection) where Piflufolastat F18 will be administered at a target dose of 9 mCi [+/-1 mCi]) after which patients will be scanned at 60-90 minutes and again at 3-4 hours.
2
Phase 3 Primary Objective - To assess the diagnostic performance of piflufolastat F 18 PET/CT to determine the presence or absence of metastatic disease in ccRCC patients.
Timeframe: From Day 1 (day of injection) where Piflufolastat F18 will be administered to 6 months post-piflufolastat F 18 administration to establish the standard of truth.
. Confirmed ccRCC with high risk of metastatic recurrence post nephrectomy pT1b or higher with G3-4 N0( or pNX where clinically N0)M0. Patients must be N0, M0 on the follow up CI not more than 60 days prior to piflufolastat F18 scan
. Patients with new radiographically suspected oligometastatic ccRCC (up to 5 metastatic lesions at presentation) planned for nephrectomy or biopsy for lesion verification of at least one suspected metastatic lesion
Exclusion criteria
. Patients administered any high energy (\>300 KeV) gamma-emitting radioisotope within five (5) physical half-lives, prior to Day 1.
. Known hypersensitivity to the components of piflufolastat F 18 or its analogs.
. Pregnant or breastfeeding females. Pregnancy testing will be performed in potentially childbearing women prior to piflufolastat F 18 administration on Day 1.
. Prior imaging with girentuximab or any PSMA-PET agent or any non-approved ccRCC imaging agent within the last 3-months prior to piflufolastat F 18 PET/CT.
. Patients who are in active systemic therapy for metastatic ccRCC prior to piflufolastat F 18 PET/CT. 30-day (12 weeks for immunotherapy) washout period is required from the last dose of systemic therapy to piflufolastat F18 administration.
. Patients who are expected to receive anti-cancer treatment between baseline conventional imaging, piflufolastat F 18 PET/CT, biopsy, or surgery.
. Evidence of any other active malignancy within the past 3 years, except non-melanoma skin cancer, carcinoma in situ, adequately treated Stage 1 cancer from which the patent is in remission and has been in remission for a minimum of 2 years. Any adjuvant or maintenance systemic chemotherapy must have been completed at least 30 days prior to piflufolastat F 18 PET/CT administration (12-week washout if immunotherapy).
. Patients with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or completing the study.