LCCC 1219: A Prospective Pilot Study Evaluating Renal Lesions Through Contrast-enhanced US in Patients With Renal Cancer and in Those With a Risk Factor for Renal Malignancy
This prospective pilot study is designed to evaluate the accuracy of contrast-enhanced
ultrasound using microbubble contrast agent (perflutren lipid; Definity®) when used to
evaluate renal lesions in two different populations; patients with known renal tumors
(Cohort 1) and patients with a risk factor for renal malignancy in whom their screening
ultrasound shows an indeterminate or possibly malignant renal mass (Cohort 2).
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Feasibility of using contrast-enhanced ultrasound in diagnosing renal malignancy in patients with known renal disease (Cohort 1) and in patients with a risk factor for renal malignancy diagnosed with suspicious or indeterminate lesions (Cohort 2)
Primary analyses will include 1) estimating the sensitivity of contrast enhanced ultrasound in Cohort 1 using the pathological outcome or biopsy result from ablative therapy as gold standard and 2) estimating sensitivity in Cohort 2 using pathology and follow-up results as gold standard (when tissue biopsy is not indicated nor surgery planned the truth standard diagnosis will be based on 12 month follow-up data of disease status). Exact 95% confidence intervals for sensitivity estimate will be reported.
Kimryn Rathmell, MD
University of North Carolina
United States: Food and Drug Administration
|Lineberger Comprehensive Cancer Center||Chapel Hill, North Carolina 27599-7305|