RecruitingNCT06076538

PET/MR for Characterization of Renal Masses (RMs)

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


Sponsor

University of Texas Southwestern Medical Center

Enrollment

97 participants

Start Date

Aug 1, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using combined PET/MR scanning (a type of imaging that combines metabolic and detailed structural imaging) to better characterize kidney masses and help determine whether they are cancerous without always needing a biopsy. **You may be eligible if...** - You are over 18 years old - You have a solid kidney mass (at least 25% of it enhances on imaging) - The kidney mass measures between 2 cm and 7 cm in size - You are able to understand and sign a consent form **You may NOT be eligible if...** - You are pregnant - You have already had a biopsy of this kidney mass - You have a contraindication to MRI (such as a metal implant) or to PET scanning Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TEST2-Deoxy-2-[18F]fluoroglucose Positron Emission Tomography/Magnetic Resonance Imaging

PET/MR scan utilizing FDG Radiopharmaceutical


Locations(1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

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NCT06076538


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