PET/MR for Characterization of Renal Masses (RMs)

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT06076538
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 2-Deoxy-2-[18F]fluoroglucose Positron Emission Tomography/Magnetic Resonance Imaging — DIAGNOSTIC_TEST
    PET/MR scan utilizing FDG Radiopharmaceutical

Study Details

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.

Key Dates

Start date
Aug 1, 2023
Status verified
Dec 2025
Primary completion
Jun 1, 2028
Completion
Jun 1, 2028

Study Design

Enrollment
97 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390
Charlton C Starcke
[email protected]
214-648-7754
Ivan Pedrosa, MD, PhD (PRINCIPAL_INVESTIGATOR)

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