Recruiting

Observational Study

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06076538

Conditions

Renal Tumor

Renal Cell Carcinoma

Renal Tumor, Benign

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

2-Deoxy-2-[18F]fluoroglucose Positron Emission Tomography/Magnetic Resonance Imaging

Study Details

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.

Conditions

Renal Tumor

Renal Cell Carcinoma

Renal Tumor, Benign

Study ID

NCT06076538

Start date

Aug 1, 2023

Status verified date

Jul, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

97 participants

Anticipated

Interventions and Outcome Measures

Arms

Patient diagnosed with incidental solid renal mass

All patients at our institution who are diagnosed with indeterminate solid SRM and without prior treatment for the tumor, renal biopsy or contraindication to PET/MRI can be included in the study. This will be a prospective, non-randomized, non-blinded observational study. Patients will then be managed following the standard of care.

Interventions

2-Deoxy-2-[18F]fluoroglucose Positron Emission Tomography/Magnetic Resonance Imaging

PET/MR scan utilizing FDG Radiopharmaceutical

Primary outcome measure

  • Prediction of SRM aggressiveness with PET [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

UTSW Radiology Clinical Research Office

214-645-1568RCRO@utsouthwestern.edu

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Radiology Clinical Research Office

214-645-1568RCRO@utsouthwestern.edu

Principal Investigator:

Robert C Sibley, MD

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Ivan Pedrossa, MD, PhD

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Aug 4, 2026

Last verified

Jul, 2026

Keywords

  • Renal Mass
  • Renal Cell Carcinoma
  • PET/MR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-08-04.