Recruiting
Phase 1

[18F]PT2385

Sponsor:

Orhan Kemal Oz

Code:

NCT04989959

Conditions

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[18F]PT2385

Positron Emission Tomography/Computed Tomography

Biopsy

Study Details

Brief 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.

Conditions

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Study ID

NCT04989959

Start date

Aug 18, 2021

Status verified date

Nov, 2025

Completion date

Aug 18, 2027

Anticipated

Primary completion date

Aug 18, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 pancreatic neuroendocrine tumor(s) planning to start belzutifan.
  • Patients with liver dysfunction will be considered "patients of special interest," and enrollment is allowed with or without criteria outlined for Cohorts 1-3. Liver dysfunction is defined clinically and is typically supported by abnormalities in imaging or laboratory studies (alanine / aspartate amino-transferase, bilirubin, alkaline phosphatase, or international normalized range (INR) for prothrombin time).
  • Women of child-bearing potential must agree to undergo and have documented a negative pregnancy test on the day of \[18F\]PT2385 administration. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or celibate by choice) who meets the following criteria:

1. Has not undergone a hysterectomy or bilateral oophorectomy; or
2. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Exclusion Criteria:

  • Uncontrolled severe and irreversible intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
  • Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
  • Claustrophobia or other contraindications to PET/CT.
  • Subjects must not weigh more than the maximum weight limit for the table for the PET/CT scanner where the study is being performed (>200 kilograms or 440 pounds).
  • For cohort 2 patients, lack of suitable sites for mandatory biopsy. For example, patients with metastatic disease restricted to the lungs that would require percutaneous biopsies with associated risk of bleeding and pneumothorax will be excluded.

Study Design

Enrollment

35 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

[18F]PT2385

\[18F\]PT2385 infusion

Positron Emission Tomography/Computed Tomography

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

Biopsy

CT-guided tumor biopsy

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kelli Key, PhD

214-648-8152Kelli.Key@UTSouthwestern.edu

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Kelli Key, PhD

214-648-8152Kelli.Key@UTSouthwestern.edu

Principal Investigator:

James Brugarolas, MD, PhD

More Information

Sponsor

Orhan Kemal Oz

Last update posted

Dec 4, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Orhan Kemal Oz on 2025-12-04.