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NCT04989959 · ClinicalTrials.gov registry record · Phase 1
[18F]PT2385 PET/CT in Patients With Renal Cell Carcinoma
A Phase 1 study of Renal Cell Carcinoma and Clear Cell Renal Cell Carcinoma, sponsored by Orhan Kemal Oz.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT04989959 is a Phase 1 study of Renal Cell Carcinoma and Clear Cell Renal Cell Carcinoma that is actively recruiting participants, run by Orhan Kemal Oz. The registered enrollment target is 35 participants, below the 243-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04989959, a Phase 1 study of Renal Cell Carcinoma and Clear Cell Renal Cell Carcinoma, is actively recruiting participants, sponsored by Orhan Kemal Oz.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- PROCEDURE Biopsy
- DRUG [18F]PT2385
- PROCEDURE Positron Emission Tomography/Computed Tomography
Study Locations (1)
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2021-08-18 |
| Est. Completion | 2027-08-18 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04989959
The ClinicalTrials.gov registry entry for NCT04989959 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 243-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (86% lower). The listed sponsor is Orhan Kemal Oz, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Biopsy is the first listed.
NCT04989959 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT04989959 about?
NCT04989959 is a clinical study titled "[18F]PT2385 PET/CT in Patients With Renal Cell Carcinoma". 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 ...
What is the current status of trial NCT04989959?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2021-08-18. Estimated completion is 2027-08-18.
What conditions does trial NCT04989959 study?
This clinical trial studies the following conditions: Renal Cell Carcinoma, Clear Cell Renal Cell Carcinoma.
What interventions are being tested in trial NCT04989959?
The interventions under investigation include: Biopsy (PROCEDURE), [18F]PT2385 (DRUG), Positron Emission Tomography/Computed Tomography (PROCEDURE).
Who is sponsoring clinical trial NCT04989959?
This trial is sponsored by Orhan Kemal Oz, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04989959 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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