NCT01751529

Open-label Pilot Evaluating Renal Lesions w/ Contrast-enhaced US in Patients w/ Renal Cancer

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective pilot study is designed to evaluate the accuracy of contrast-enhanced ultrasound 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).

Detailed description

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).

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
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.
DRUG	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.

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2012-12-18
• Last updated: 2017-03-17

Locations

1 site across 1 country: United States