Evaluating kidney tumors using biopsy and imaging tests
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
Loyola University · NCT05728957
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Loyola University (other) |
| Locations | 1 site (Maywood, Illinois) |
| Trial ID | NCT05728957 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with clinically localized renal tumors that are suspicious for malignancy.
Not a fit: Patients with evidence of clinical nodal or distant metastasis or those who are pregnant may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Maywood, Illinois
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Kidney Tumor, Renal Benign Neoplasm, Renal Malignant Tumor, Survey Questions, Benign, Malignant, Nuclear Imaging, Computed Tomography