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NCT06076538 · ClinicalTrials.gov registry record
PET/MR for Characterization of Renal Masses (RMs)
A clinical trial of Renal Cell Carcinoma and Renal Tumor, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- 97
- Enrollment target
- 1
- Study location
NCT06076538: Recruiting study of Renal Cell Carcinoma and Renal Tumor, sponsored by University of Texas Southwestern Medical Center.
NCT06076538 is a study of Renal Cell Carcinoma and Renal Tumor that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 97 participants, below the 242-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06076538, a study of Renal Cell Carcinoma and Renal Tumor, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- 97 participants
- Enrollment target
- 1
- Study location
Study Summary
The frequency of kidney tumors found incidentally on imaging studies performed for unrelated reasons continues to increase leading to more surgeries and ablations for the treatment of renal masses thought to be cancer. However, about 20% of these masses are not cancerous and do not require treatment. Many cancerous kidney tumors are indolent and can be followed safely with imaging (i.e., particularly tumors \<2 cm and in patients with limited life expectancy), while some tumors are both malignant and aggressive, with a higher potential to spread outside the kidney and require treatment. The purpose of this observational study is to assess the ability of Fludeoxyglucose (18F) (FDG) PET/MR to distinguish different types of kidney tumors. The investigators hypothesize that PET/MR will better show differences between aggressive and both indolent and benign kidney masses compared to the currently used radiologic scans. Participants will be selected from those who have been scheduled to receive a contrast-enhanced MRI for their regular care due to a suspicious kidney mass. Participants will have their MRI on a hybrid PET/MR scanner capable of obtaining both MRI and PET images. While they are receiving their standard of care MRI exam, patients will also receive a research FDG PET exam. Participants will have an IV placed for administration of the MRI contrast agent, just as they would if they were not taking part in the study. The same IV will be used to give the FDG radiopharmaceutical for the PET scan and furosemide (a diuretic), to help empty the bladder before the scan and help better see the kidneys on the scans. Both FDG and furosemide are FDA approved medications. Participants will have only one visit with the research team which will last \~2.5 hours and will include collection of the participant's regularly scheduled MRI. If participants undergo surgery to remove the tumor, the study will collect samples of the removed tissue for research. If participants recei
Primary Outcome
To test the difference in mean SUVmax between HG malignant renal masses and other (LG malignancies and benign) renal masses.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST 2-Deoxy-2-[18F]fluoroglucose Positron Emission Tomography/Magnetic Resonance Imaging
Study Locations (1)
Texas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2023-08-01 |
| Est. Completion | 2028-06-01 |
What NCT06076538 shows while recruiting
NCT06076538 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 242-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (60% lower).
The record links to 3 conditions, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which 2-Deoxy-2-[18F]fluoroglucose Positron Emission Tomography/Magnetic Resonance Imaging is the first listed.
NCT06076538 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06076538 about?
NCT06076538 is a clinical study titled "PET/MR for Characterization of Renal Masses (RMs)". The frequency of kidney tumors found incidentally on imaging studies performed for unrelated reasons continues to increase leading to more surgeries and ablations for the treatment of renal masses thought to be cancer. However, about 20% of these masses are not cancerous and do not require treatment...
What is the current status of trial NCT06076538?
This trial is currently recruiting. The enrollment target is 97 participants. The study started on 2023-08-01. Estimated completion is 2028-06-01.
What conditions does trial NCT06076538 study?
This clinical trial studies the following conditions: Renal Cell Carcinoma, Renal Tumor, Renal Tumor, Benign.
What interventions are being tested in trial NCT06076538?
The interventions under investigation include: 2-Deoxy-2-[18F]fluoroglucose Positron Emission Tomography/Magnetic Resonance Imaging (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06076538?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06076538 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 NCT06076538's enrollment target sits among peer trials
97 55th of 121 higher than 67 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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