NCT06076538 PET/MR for Characterization of Renal Masses (RMs)
| NCT ID | NCT06076538 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Renal Tumor |
| Study Type | OBSERVATIONAL |
| Enrollment | 97 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 97 participants in total. It began in 2023-08-01 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 receive a biopsy of the tumor, the study may collect an additional sample of the tumor for research. After the PET/MRI, participants will not have additional visits with the study team, but the study team may call every 6-12 months for up to 2 years to see how they are doing and ask about their health. The study team will review the medical record for any changes to their diagnosis, updates to their medical history, new scans ordered by their regular doctor, or recent lab or biopsy results.
Eligibility Criteria
Inclusion Criteria: * Patients with known solid (\>25% total volume enhances) renal mass * Renal mass size measuring \>2 to ≤7 cm * Age \>18 years * Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: * Pregnancy * Prior percutaneous biopsy of the renal mass * Prior treatment of the renal mass * Prior hemorrhage in the renal mass * Contraindication to MRI or PET * Renal mass not eligible for ccLS based on prior imaging (i.e., containing macroscopic fat \[classic angiomyolipoma\] or enhancing less than 25% of its volume \[considered a cystic renal mass\]) * Genetic syndrome predisposing to renal masses (e.g., VHL, BHD, TSC, etc.); * More than 3 renal masses at time of initial diagnosis
Contact & Investigator
Robert C Sibley, MD
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT06076538 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Renal Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06076538 currently recruiting?
Yes, NCT06076538 is actively recruiting participants. Contact the research team at RCRO@utsouthwestern.edu for enrollment information.
Where is the NCT06076538 trial being conducted?
This trial is being conducted at Dallas, United States, Houston, United States.
Who is sponsoring the NCT06076538 clinical trial?
NCT06076538 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Robert C Sibley, MD at University of Texas Southwestern Medical Center. The trial plans to enroll 97 participants.