Open-label Pilot Evaluating Renal Lesions w/ Contrast-enhaced US in Patients w/ Renal Cancer
NCT01751529 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2017-03-17
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).
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
UNC Lineberger Comprehensive Cancer Center
lead OTHER
Principal Investigators
-
Kimryn Rathmell, MD · University of North Carolina
-
Wui Chong, MBBS, FRCR · University of North Carolina
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-05-31
- Primary Completion
- 2015-11-30
- Completion
- 2015-11-30
Countries
- United States
Study Locations
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