Open-label Pilot Evaluating Renal Lesions w/ Contrast-enhaced US in Patients w/ Renal Cancer
|ClinicalTrials.gov Identifier: NCT01751529|
Recruitment Status : Completed
First Posted : December 18, 2012
Last Update Posted : March 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Procedure: Contrast-enhanced Ultrasound Drug: Perflutren lipid||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
|Experimental: Contrast-enhanced Ultrasound||
Procedure: Contrast-enhanced Ultrasound
All patients will undergo a contrast-enhanced ultrasound prior to planned resection or ablative therapy or as part of routine screening for kidney cancer.
Other Name: Contrast-enhanced USDrug: Perflutren lipid
All patients will receive a contrast-enhanced ultrasound using microbubble contrast agent (perflutren lipid; Definity®) prior to planned resection or ablative therapy or as part of routine screening for kidney cancer.
Other Name: Definity®
- 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) [ Time Frame: 12 months ]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.
- Feasibility of comparing the sensitivity and specificity of contrast enhanced ultrasound to traditional imaging techniques (CT and MRI) in detecting renal lesions in patients already diagnosed with a renal malignancy [ Time Frame: 12 months ]The estimates obtained in Cohort 1 will be compared to the published figures of the conventional CT and MRI method. For Cohort 2 patients who undergo surgery, the percentage of subjects who are correctly diagnosed (benign and malignancy) will be reported along with exact 95% CI. Frequency tables will be used to describe associations. Appropriate descriptive summary statistics such as mean, median and standard deviation of tumor measurement will be provided to quantify and characterize renal masses.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751529
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Kimryn Rathmell, MD||University of North Carolina|
|Principal Investigator:||Wui Chong, MBBS, FRCR||University of North Carolina|