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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: Recruiting Phase 1 study of Renal Cell Carcinoma and Clear Cell Renal Cell Carcinoma, sponsored by Orhan Kemal Oz.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Correlation between \[18F\]PT2385 PET avidity and HIF2α expression in primary tumors
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 |
What NCT04989959 shows while recruiting
NCT04989959 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 243-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (86% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT04989959's enrollment target sits among peer trials
35 89th of 121 higher than 33 of 121 other Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Renal Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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