Using PET/MR to identify types of kidney tumors
Prospective Observational Study Using PET/MR for Characterization of Renal Masses (RMs)
This study is testing if a new type of imaging can help doctors tell the difference between aggressive and harmless kidney tumors in people with certain kidney masses.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 97 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06076538 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of Fludeoxyglucose (18F) PET/MR imaging in distinguishing between aggressive and benign kidney tumors. With the rising incidence of incidental renal masses detected through imaging, the study seeks to address the issue of over-treatment by providing a more accurate diagnostic tool. Participants will include individuals with solid renal masses measuring between 2 to 7 cm, and the study will assess the imaging's ability to differentiate tumor types compared to standard radiologic scans.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a known solid renal mass measuring between 2 to 7 cm.
Not a fit: Patients with prior treatment of the renal mass or those with contraindications to MRI or PET will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could reduce unnecessary surgeries and treatments for patients with benign or indolent kidney tumors.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for tumor characterization, but this specific approach with PET/MR is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dallas, Texas
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Ivan Pedrosa, MD, PhD — University of Texas Southwestern Medical Center
- Study coordinator: UTSW Radiology Clinical Research Office
- Email: RCRO@utsouthwestern.edu
- Phone: 214-645-1568
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.