Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT04989959

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

Led by Orhan Kemal Oz · Updated on 2025-12-04

35

Participants Needed

1

Research Sites

313 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand and willing to sign informed consent including PET/CT and biopsy if in cohort 2
  • Ability to lie still for a 30- to 60-minute PET/CT scan
  • Patients must be in one of the following groups:
    1. Suspected RCC planned for surgery (Cohort 1)
    2. Metastatic clear cell RCC or VHL syndrome with RCC with planned biopsy or resection of metastatic site (Cohort 2)
    3. VHL syndrome with RCC, CNS hemangioblastoma, and/or pancreatic neuroendocrine tumor(s) planning to start belzutifan (Cohort 3)
  • Patients with liver dysfunction may be enrolled with or without meeting the above cohort criteria
  • Women of child-bearing potential must have a documented negative pregnancy test on the day of [18F]PT2385 administration
Not Eligible

You will not qualify if you...

  • Uncontrolled severe or irreversible illness or psychiatric/social conditions limiting study compliance
  • Pregnant or nursing women
  • Claustrophobia or contraindications to PET/CT
  • Weight exceeding PET/CT scanner limit (>200 kilograms or 440 pounds)
  • For cohort 2, lack of suitable biopsy sites, such as metastatic disease limited to lungs with high biopsy risks

AI-Screening

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Trial Site Locations

Total: 1 location

1

UT Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

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Research Team

K

Kelli Key, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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