Efficacy of Ultrasound Contrast Agent to Assess Renal Masses

Phase 2

Completed

• Conditions: Renal Cell Carcinoma
• Interventions: Drug: Definity

• Registration Number: NCT01062178
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-01-22
• Study First Submitted QC: 2010-02-03
• Study First Posted: 2010-02-04
• Primary Completion: 2012-10
• Study Completion: 2012-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

Inclusion Criteria

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
comparison to biopsy	Definity	Comparing contrast enhanced US with biopsy result

Primary Outcome Measures

Name	Time	Method
biopsy	12 to 18 months

Trial Locations

Locations (1)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada