An Exploratory Study of [18F]PT2385 PET/CT in Patients With Renal Cell Carcinoma
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.
Description
HIF2α is an emerging therapeutic target in RCC. Proof-of-principle experiments in mice have demonstrated the feasibility of PET/CT imaging with novel radiotracers, \[11C\] and \[18F\]PT2385, to assess HIF2α expression in RCC. \[18F\]PT2385 has been proposed in this study for practical imaging of HIF2α. This is a non-therapeutic research study. Patients with localized or metastatic RCC will undergo imaging with \[18F\]PT2385. Patients will have the opportunity to ask questions regarding the procedure. A peripheral intravenous line will be placed for \[18F\]PT2385 administration. Patients will…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Ability to understand and the willingness to sign a written informed consent that includes study interventions (PET/CT and, if cohort 2, mandatory biopsy). * Ability to lie still for a 30- to 60-minute PET/CT scan. * One of the following: 1. Cohort 1. Patients with suspected RCC planned for surgery. 2. Cohort 2. Patients with metastatic ccRCC or VHL syndrome and RCC. Biopsy is required (planned resection for treatment reasons of a metastatic site is acceptable in lieu of the biopsy). 3. Cohort 3. Patients with VHL syndrome with RCC, CNS hemangioblastoma, and/or pa…
Interventions
- Drug[18F]PT2385
\[18F\]PT2385 infusion
- ProcedurePositron Emission Tomography/Computed Tomography
PET/CT scan after \[18F\]PT2385 infusion
- ProcedureBiopsy
CT-guided tumor biopsy
Location
- UT Southwestern Medical CenterDallas, Texas