PET/MR for Characterization of Renal Masses (RMs)

NCT06076538 | Recruiting DMC

• 1 other identifier: STU-2022-1158
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

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 Tumor, Benign; Renal Cell Carcinoma

Keywords

Renal Mass; Renal Cell Carcinoma; PET/MR

Outcome Measures

Primary Outcomes (1)

• Prediction of SRM aggressiveness with PET

  To test the difference in mean SUVmax between HG malignant renal masses and other (LG malignancies and benign) renal masses.

  Baseline

Secondary Outcomes (2)

• Prediction of SRM aggressiveness with the metabolic clear cell likelihood score (m-ccLS)

  Baseline

• Prediction of aggressive clear cell histology with the metabolic clear cell likelihood score (m-ccLS)

  Baseline

Study Arms (1)

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.

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

Interventions

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

PET/MR scan utilizing FDG Radiopharmaceutical

Also known as: FDG PET/MR

Patient diagnosed with incidental solid renal mass

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients will complete their clinically indicated MRI with the addition of the research infusion of the FDA approved FDG radiotracer and PET portion of the scan. Eligibility waivers are not permitted. Subjects must meet all of the inclusion and exclusion criteria to be registered to the study.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Radiological Society of North America: collaborator
• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

For patients undergoing standard of care biopsy, an extra core will be obtained for future research from participants who opt-in to have extra core collected when they sign informed consent form. If the renal mass is resected surgically, a piece of discarded tissue will be collected for similar correlative studies. The extra core or the discarded tissue will be used for metabolomics analysis to understand the correlation of FDG uptake and tumor metabolism.

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ivan Pedrosa, MD, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

UTSW Radiology Clinical Research Office

CONTACT

214-645-1568; RCRO@utsouthwestern.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Radiology

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: October 11, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)