Back to resultsEfficacy of Ultrasound Contrast Agent to Assess Renal Masses
Primary Purpose
Renal Cell Carcinoma
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Definity
Sponsored by
About this trial
This is an interventional diagnostic trial for Renal Cell Carcinoma focused on measuring Small renal Mass, Contrast Enhanced Ultrasound, Renal Cell Carcinoma, noninvasive diagnosis of RCC
Eligibility Criteria
Inclusion Criteria:
- Patients with newly diagnosed Renal mass < 4 cmm, who are going to undergo diagnostic CT, MRI or biopsy.
Sites / Locations
- Toronto General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
comparison to biopsy
Arm Description
Comparing contrast enhanced US with biopsy result
Outcomes
Primary Outcome Measures
biopsy
Secondary Outcome Measures
Full Information
NCT ID
NCT01062178
First Posted
January 22, 2010
Last Updated
March 7, 2016
Sponsor
University Health Network, Toronto
Collaborators
Lantheus Medical Imaging
1. Study Identification
Unique Protocol Identification Number
NCT01062178
Brief Title
Efficacy of Ultrasound Contrast Agent to Assess Renal Masses
Official Title
The Comparison of Accuracy of Contrast Enhanced Ultrasound on Diagnosis of Small Renal Masses and Distinguishing Renal Cell Carcinomas From Other Renal Masses, With Biopsy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Lantheus Medical Imaging
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients with an incidentally discovered small renal masses (SRM) < 4 cm in diameter are included. All patients will undergo biopsy for tissue diagnosis. Most patients will be followed by imaging. Study intervention includes low MI US to be performed following both bolus and infusion injection of Definity contrast. Presence and absence of vascularity, pattern of vascularity, and TIC values will be correlated with the final pathology to find features differentiating benign from malignant masses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
Small renal Mass, Contrast Enhanced Ultrasound, Renal Cell Carcinoma, noninvasive diagnosis of RCC
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
167 (Actual)
8. Arms, Groups, and Interventions
Arm Title
comparison to biopsy
Arm Type
Experimental
Arm Description
Comparing contrast enhanced US with biopsy result
Intervention Type
Drug
Intervention Name(s)
Definity
Intervention Description
Definity is the contrast agent which is going to be injected in a bolus and infusion forms during the ultrasound performance.
Primary Outcome Measure Information:
Title
biopsy
Time Frame
12 to 18 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with newly diagnosed Renal mass < 4 cmm, who are going to undergo diagnostic CT, MRI or biopsy.
Facility Information:
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Ultrasound Contrast Agent to Assess Renal Masses
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