Efficacy of Ultrasound Contrast Agent to Assess Renal Masses

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
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
  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
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

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, Renal Cell
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014