Evaluating kidney tumors using biopsy and imaging tests
Official title: A Prospective Diagnostic Cohort Study to Compare the Accuracy of Renal Mass Biopsy, PEER, and 99mTc-sestamibi SPECT/CT for Patients With Clinically Localized Renal Tumors
Run by Loyola University · NCT05728957 · Data updated 2026-11-12
This study is testing whether a combination of biopsy and imaging tests can help people with kidney tumors find out if their tumors are cancerous or not, to make better treatment decisions.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Loyola University Academic / other |
| Locations | 1 site (Maywood, Illinois) |
| Status | Recruiting |
| Started | February 1, 2023 |
| Main results expected | February 2033 |
| Study ends | December 2033 |
| Registry record updated | March 19, 2025 |
| Trial ID | NCT05728957 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older diagnosed with clinically localized renal tumors that are suspicious for malignancy.
✕Probably not a fit
Patients with evidence of clinical nodal or distant metastasis or those who are pregnant may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to differentiate between benign and malignant kidney tumors using renal mass biopsy, PEER, and 99mTc-sestamibi SPECT/CT imaging. Participants diagnosed with localized renal tumors will undergo these diagnostic tests to assess their accuracy in identifying tumor types. Additionally, patients will complete surveys regarding their health and treatment decisions at the beginning and end of the study. The findings could improve pre-surgical decision-making for kidney tumor treatment.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of kidney tumors, allowing for better treatment decisions.
How similar studies have gone: Previous studies have shown promise in using imaging tests like 99mTc-sestamibi SPECT/CT for identifying benign kidney tumors, but this specific combination of approaches is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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's running
-
Loyola University Medical Center
Maywood, Illinois, United States Recruiting
Study contacts
- Principal investigator: Hiten D Patel, MD, MPH — Loyola University
- Study coordinator: Gopal N Gupta, MD
- Email: gogupta@lumc.edu
- Phone: 708-216-8467
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.