Efficacy of Ultrasound Contrast Agent to Assess Renal Masses

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. Identifier: NCT01062178
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : March 8, 2016
Lantheus Medical Imaging
Information provided by (Responsible Party):
University Health Network, Toronto

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
Renal Cell Carcinoma Drug: Definity Phase 2

Study Type : Interventional  (Clinical Trial)
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 : October 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Ultrasound
Drug Information available for: Perflutren
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. biopsy [ Time Frame: 12 to 18 months ]

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

Inclusion Criteria:

  • Patients with newly diagnosed Renal mass < 4 cmm, who are going to undergo diagnostic CT, MRI or biopsy.

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 identifier (NCT number): NCT01062178

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

Responsible Party: University Health Network, Toronto Identifier: NCT01062178     History of Changes
Other Study ID Numbers: 08-0512-CE
First Posted: February 4, 2010    Key Record Dates
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, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases