Efficacy of Ultrasound Contrast Agent to Assess Renal Masses

This study has been completed.
Sponsor:
Collaborator:
Lantheus Medical Imaging
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01062178
First received: January 22, 2010
Last updated: March 7, 2016
Last verified: March 2016
  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 ]

Enrollment: 167
Study Start Date: October 2009
Study Completion Date: December 2012
Primary Completion Date: October 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062178

Locations
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Lantheus Medical Imaging
  More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01062178     History of Changes
Other Study ID Numbers: 08-0512-CE 
Study First Received: January 22, 2010
Last Updated: March 7, 2016
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
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on May 24, 2016