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Efficacy of Ultrasound Contrast Agent to Assess Renal Masses

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01062178
First Posted: February 4, 2010
Last Update Posted: March 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Lantheus Medical Imaging
Information provided by (Responsible Party):
University Health Network, Toronto
  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
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

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: January 22, 2010
First Posted: February 4, 2010
Last Update Posted: March 8, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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