Clinical trial Recruiting at 2 sites Observational Ages 18 and up

Using PET/MR to identify types of kidney tumors

Official title: Prospective Observational Study Using PET/MR for Characterization of Renal Masses (RMs)

Run by University of Texas Southwestern Medical Center · NCT06076538 · Data updated 2026-11-12

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 typeObservational
Ages18 Years and up
SexAll
Enrollment97 (estimated)
SponsorUniversity of Texas Southwestern Medical Center
Academic / other
Drugs / interventionsradiation
Locations2 sites (Dallas, Texas and 1 other locations)
StatusRecruiting
StartedAugust 1, 2023
Main results expectedJune 1, 2028
Study endsJune 1, 2028
Registry record updatedAugust 4, 2026
Trial IDNCT06076538 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 with a known solid renal mass measuring between 2 to 7 cm.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies have shown promise in using advanced imaging techniques for tumor characterization, but this specific approach with PET/MR is relatively novel.

Who can join: the full rules

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 it's running

  • University of Texas Southwestern Medical Center
    Dallas, Texas, United States
    Recruiting
  • The University of Texas MD Anderson Cancer Center
    Houston, Texas, United States
    Recruiting

Study contacts

  • Principal investigator: Robert C Sibley, MD — University of Texas Southwestern Medical Center
  • Study coordinator: UTSW Radiology Clinical Research Office
  • Email: RCRO@utsouthwestern.edu
  • Phone: 214-645-1568

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.