Clinical Research Directory
Browse clinical research sites, groups, and studies.
[18F]PT2385 PET/CT in Patients With Renal Cell Carcinoma
Sponsor: Orhan Kemal Oz
Summary
This is an exploratory study to assess \[18F\]PT2385 Positron Emission Tomography/Computed Tomography (PET/CT) in patients with renal cell carcinoma (RCC). This is an open-label, nontherapeutic trial. The main objective is to correlate hypoxia-inducible factor-2alpha (HIF2α) levels as determined by an investigational \[18F\]PT2385 PET/CT scan with the levels on subsequently obtained tissue by HIF2α immunohistochemistry (IHC). There will be three cohorts. The first pre-surgical cohort will have \[18F\]PT2385 PET/CT prior to nephrectomy. The uptake and retention on Positron Emission Tomography (PET), quantified as standardized uptake value (SUV) max and mean, abbreviated SUV henceforth will be correlated with HIF2α levels by IHC on the primary tumor. The second cohort will comprise patients with metastatic clear cell renal carcinoma (ccRCC). SUV will be correlated with HIF2α levels measured by IHC on a biopsy sample from a metastasis. Both low- and high-avidity sites will be biopsied and tracer uptake correlated with HIF2α IHC. A third cohort will include patients with Von Hippel-Lindau (VHL) syndrome and any of the following disease manifestations - RCC, central nervous system (CNS) hemangioblastoma, and/or pancreatic neuroendocrine tumor(s). Investigational imaging will evaluate HIF2α expression within a tumor type and across different tumor types. A biopsy is encouraged but not mandatory for this cohort.
Official title: An Exploratory Study of [18F]PT2385 PET/CT in Patients With Renal Cell Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2021-08-18
Completion Date
2027-08-18
Last Updated
2025-12-04
Healthy Volunteers
No
Interventions
[18F]PT2385
\[18F\]PT2385 infusion
Positron Emission Tomography/Computed Tomography
PET/CT scan after \[18F\]PT2385 infusion
Biopsy
CT-guided tumor biopsy
Locations (1)
UT Southwestern Medical Center
Dallas, Texas, United States