Renal Mass Biopsy, PEER, and 99mTc-sestamibi SPECT/CT for Patients With Clinically Localized Renal Tumors
Recruiting now
Conditions studied: Kidney Tumor, Renal Benign Neoplasm, Renal Malignant Tumor
In brief
The goal of this clinical trial is to better tell apart whether kidney tumors are benign (not cancer) or malignant (cancer) based on a biopsy or imaging tests and ask patients how they feel about decisions they make about treatment of their kidney tumor. The main objectives are: To estimate and compare the diagnostic accuracy of renal mass biopsy alone, PEER (with renal mass biopsy), and 99mTc-sestamibi SPECT/CT (with renal mass biopsy for hot tumors) to differentiate malignant and benign renal tumors. To estimate and compare the diagnostic accuracy of renal mass biopsy, PEER (with renal mass biopsy), and 99mTc-sestamibi SPECT/CT (with renal mass biopsy for hot tumors) to differentiate oncocytoma from chromophobe RCC. Participants will be asked to complete survey questions related to their health and kidney tumor at the start and end of the study. These can be done on paper, electronically, or by telephone.
Key facts
- Study ID
- NCT05728957
- Run by
- Loyola University
- People needed
- 100
- Starts
- 2023-02-01
- Expected to finish
- 2033-12-01
- Last updated by the study team
- 2025-03-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants diagnosed with a clinically localized (cT1) renal tumor ≤7cm in size with a solid component suspicious for malignancy based on cross-sectional imaging
- Pre-existing CT images of the mass with and without contrast or planned CT to ensure both with and without contrast images of the mass have been obtained within a 365-day window
- Participants must be greater than or equal to 18 years of age
- Eligible or planned to undergo partial or radical nephrectomy as determined by primary urologist
- Eligible or planned to receive renal mass biopsy as determined by primary urologist
- Estimated glomerular filtration rate of ≥30 ml/min/1.73 m2 as calculated by the CKD-EPI (Chronic Kidney Disease-Epidemiology Collaboration) Equation
You may not qualify if…
- Participants must not be pregnant (as determined by local policy by radiology / imaging center)
- Participants must not have evidence of clinical nodal or distant metastasis.
- Participants must not have had a history of other malignancy with concern for renal metastasis.
- Participants must not have any known allergy to technetium or sestamibi.
Where it is running
- Loyola University Medical Center — Maywood, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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