Actively Recruiting
An Exploratory Study of [18F]PT2385 PET/CT in Patients With Renal Cell Carcinoma
Led by Orhan Kemal Oz · Updated on 2025-12-04
35
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of an investigational imaging agent called [18F]PT2385 in patients with renal cell carcinoma (RCC), including clear cell RCC and those with Von Hippel-Lindau (VHL) syndrome. The study is designed to explore how well this imaging method can measure levels of a protein called hypoxia-inducible factor-2alpha (HIF2b1) in tumors, which is important for understanding the disease. It is an open-label, non-therapeutic trial involving three patient groups with different disease presentations. Participants will receive an intravenous injection of [18F]PT2385 followed by PET/CT or PET/MRI scans to observe the distribution and uptake of the tracer in tumors. The first group consists of patients scheduled for surgery, who will have imaging before nephrectomy, with results compared to tissue analysis after surgery. The second group includes patients with metastatic clear cell RCC, who will have imaging and a mandatory biopsy of metastatic sites. The third group involves patients with VHL syndrome and various tumors, who will undergo imaging and are encouraged, but not required, to have a biopsy. Some participants may have repeat imaging after initial dosimetry assessments. Throughout the study, patients will undergo multiple imaging sessions, including dynamic and whole-body scans at different time points after tracer injection to analyze tracer kinetics and distribution. Researchers will collect tissue samples for comparison with imaging findings, and participants will continue with standard or experimental treatments as advised by their doctors. The study aims to correlate imaging results with tissue levels of HIF2b1 over up to five years, monitoring safety and feasibility during the process.
CONDITIONS
Brief Title
[18F]PT2385 PET/CT in Patients With Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign informed consent including study interventions
- Ability to lie still for a 30- to 60-minute PET/CT scan
- Patients planned for surgery with suspected RCC (Cohort 1)
- Patients with metastatic clear cell RCC or VHL syndrome and RCC requiring biopsy or planned metastatic site resection (Cohort 2)
- Patients with VHL syndrome with RCC, CNS hemangioblastoma, and/or pancreatic neuroendocrine tumors planning to start belzutifan (Cohort 3)
- Women of child-bearing potential must have a negative pregnancy test on the day of [18F]PT2385 administration
- Patients with liver dysfunction may be enrolled with or without meeting above cohort criteria
You will not qualify if you...
- Uncontrolled severe or irreversible illness or psychiatric/social issues limiting study compliance
- Pregnant or nursing women
- Claustrophobia or other contraindications to PET/CT
- Weight exceeding PET/CT scanner table limit (>200 kilograms or 440 pounds)
- For Cohort 2, lack of suitable biopsy sites, such as metastatic disease limited to lungs with high biopsy risk
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day for imaging; additional imaging visits up to 4 hours post-injection for some participants
Participants receive an intravenous injection of [18F]PT2385 and undergo PET/CT or PET/MRI imaging to assess HIF2α expression in renal cell carcinoma. Imaging includes dynamic scans and whole-body scans at multiple time points depending on cohort assignment.
1 to 3 imaging visits depending on cohort and imaging protocol
Duration - Single visit
Participants in certain cohorts undergo a CT-guided tumor biopsy to obtain tissue samples for correlation with imaging results. Biopsy is mandatory in the metastatic cohort and encouraged but optional in the VHL syndrome cohort.
1 visit (in-person)
Duration - Varies by participant
Participants in the pre-surgical cohort undergo surgery following imaging to remove renal tumors. Post-operative care is provided as per standard clinical practice.
1 surgery visit plus routine post-operative visits as needed
Duration - Up to 5 years
Participants may undergo repeat [18F]PT2385 PET imaging for dosimetry studies or clinical follow-up. Standard or experimental treatments for renal cell carcinoma continue as directed by the treating physician.
Visits as needed for repeat imaging or clinical follow-up
Trial Site Locations
Total: 1 location
1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
K
Kelli Key, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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