Efficacy of Ultrasound Contrast Agent to Assess Renal Masses
This study is currently recruiting participants.
Verified February 2010 by University Health Network, Toronto
Sponsor:
University Health Network, Toronto
Collaborator:
Lantheus Medical Imaging
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01062178
First received: January 22, 2010
Last updated: February 24, 2010
Last verified: February 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Renal Cell Carcinoma |
Drug: Definity |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by University Health Network, Toronto:
Primary Outcome Measures:
- biopsy [ Time Frame: 12 to 18 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 167 |
| Study Start Date: | October 2009 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with newly diagnosed Renal mass < 4 cmm, who are going to undergo diagnostic CT, MRI or biopsy.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01062178
Contacts
| Contact: mostafa atri, MD | 416 340 4800 ext 3253 | mostafa.atri@uhn.on.ca |
Locations
| Canada, Ontario | |
| Toronto General Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Contact: mostafa atri, MD 416 340 4800 ext 3253 mostafa.atri@uhn.on.ca | |
| Principal Investigator: mostafa atri, md | |
Sponsors and Collaborators
University Health Network, Toronto
Lantheus Medical Imaging
More Information
No publications provided
| Responsible Party: | Mostafa Atri, University Health Network |
| ClinicalTrials.gov Identifier: | NCT01062178 History of Changes |
| Other Study ID Numbers: | 08-0512-CE |
| Study First Received: | January 22, 2010 |
| Last Updated: | February 24, 2010 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University Health Network, Toronto:
|
Small renal Mass Contrast Enhanced Ultrasound Renal Cell Carcinoma noninvasive diagnosis of RCC |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013