RECRUITING

PET/MR for Characterization of Renal Masses (RMs)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-08-01
Study Completion:2028-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06076538

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with known solid (\>25% total volume enhances) renal mass
  2. * Renal mass size measuring \>2 to ≤7 cm
  3. * Age \>18 years
  4. * Ability to understand and the willingness to sign a written informed consent.
  1. * Pregnancy
  2. * Prior percutaneous biopsy of the renal mass
  3. * Prior treatment of the renal mass
  4. * Prior hemorrhage in the renal mass
  5. * Contraindication to MRI or PET
  6. * 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 \[considered a cystic renal mass\])
  7. * Genetic syndrome predisposing to renal masses (e.g., VHL, BHD, TSC, etc.);
  8. * More than 3 renal masses at time of initial diagnosis

Contacts and Locations

Study Contact

UTSW Radiology Clinical Research Office
CONTACT
214-645-1568
RCRO@utsouthwestern.edu

Principal Investigator

Ivan Pedrosa, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center

Study Locations (Sites)

University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Ivan Pedrosa, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Texas Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-01
Study Completion Date2028-06-01

Study Record Updates

Study Start Date2023-08-01
Study Completion Date2028-06-01

Terms related to this study

Keywords Provided by Researchers

  • Renal Mass
  • Renal Cell Carcinoma
  • PET/MR

Additional Relevant MeSH Terms

  • Renal Tumor
  • Renal Cell Carcinoma
  • Renal Tumor, Benign