Efficacy of Ultrasound Contrast Agent to Assess Renal Masses
Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT01062178
Collaborator
Lantheus Medical Imaging (Industry)
167
1
1
38
4.4
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
167 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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 Start Date
:
Oct 1, 2009
Actual Primary Completion Date
:
Oct 1, 2012
Actual Study Completion Date
:
Dec 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: comparison to biopsy Comparing contrast enhanced US with biopsy result |
Drug: Definity
Definity is the contrast agent which is going to be injected in a bolus and infusion forms during the ultrasound performance.
|
Outcome Measures
Primary Outcome Measures
- biopsy [12 to 18 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients with newly diagnosed Renal mass < 4 cmm, who are going to undergo diagnostic CT, MRI or biopsy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Toronto General Hospital | Toronto | Ontario | Canada | M5G 2C4 |
Sponsors and Collaborators
- University Health Network, Toronto
- Lantheus Medical Imaging
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01062178
Other Study ID Numbers:
- 08-0512-CE
First Posted:
Feb 4, 2010
Last Update Posted:
Mar 8, 2016
Last Verified:
Mar 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by University Health Network, Toronto
Additional relevant MeSH terms: