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RECRUITING
NCT04989959
PHASE1

[18F]PT2385 PET/CT in Patients With Renal Cell Carcinoma

Sponsor: Orhan Kemal Oz

View on ClinicalTrials.gov

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

DRUG

[18F]PT2385

\[18F\]PT2385 infusion

PROCEDURE

Positron Emission Tomography/Computed Tomography

PET/CT scan after \[18F\]PT2385 infusion

PROCEDURE

Biopsy

CT-guided tumor biopsy

Locations (1)

UT Southwestern Medical Center

Dallas, Texas, United States