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Patient diagnosed with incidental solid renal mass for Kidney Cancer

N/A
Recruiting
Led By Ivan Pedrosa, MD, PhD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Study 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.

Eligible Conditions
  • Kidney Tumors
  • Benign Renal Tumor
  • Kidney Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Prediction of SRM aggressiveness with PET
Secondary outcome measures
Prediction of SRM aggressiveness with the metabolic clear cell likelihood score (m-ccLS)
Prediction of aggressive clear cell histology with the metabolic clear cell likelihood score (m-ccLS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patient diagnosed with incidental solid renal massExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,052 Previous Clinical Trials
1,054,788 Total Patients Enrolled
Ivan Pedrosa, MD, PhDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~65 spots leftby Jun 2028