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

Part of paid clinical trials in Dallas, Texas.

Sponsor
Orhan Kemal Oz
Study ID
NCT04989959
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [18F]PT2385 — DRUG
    \[18F\]PT2385 infusion
  • Positron Emission Tomography/Computed Tomography — PROCEDURE
    PET/CT scan after \[18F\]PT2385 infusion
  • Biopsy — PROCEDURE
    CT-guided tumor biopsy

Study Details

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.

Key Dates

Start date
Aug 18, 2021
Status verified
Nov 2025
Primary completion
Aug 18, 2026
Completion
Aug 18, 2027

Study Design

Enrollment
35 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Pre-Surgical
    Patients with suspected RCC planned for surgery
  • Experimental: Metastatic or VHL Syndrome
    Patients with metastatic ccRCC or VHL syndrome and RCC
  • Experimental: Planned belzutifan treatment
    Patients with VHL syndrome with RCC, CNS hemangioblastoma, and/or pancreatic neuroendocrine tumor(s) planning to start belzutifan.

Primary Outcome Measure

Correlation between [18F]PT2385 and HIF2α [ Time Frame: Up to 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CenterDallasTexas75390
Kelli Key, PhD
[email protected]
214-648-8152
James Brugarolas, MD, PhD (PRINCIPAL_INVESTIGATOR)

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