Efficacy of Ultrasound Contrast Agent to Assess Renal Masses

NCT ID: NCT01062178

Last Updated: 2016-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2012-12-31

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.

Conditions

Renal Cell Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

comparison to biopsy

Comparing contrast enhanced US with biopsy result

Group Type: EXPERIMENTAL

Definity

Intervention Type: DRUG

Definity is the contrast agent which is going to be injected in a bolus and infusion forms during the ultrasound performance.

Interventions

Definity

Definity is the contrast agent which is going to be injected in a bolus and infusion forms during the ultrasound performance.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lantheus Medical Imaging

INDUSTRY

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Toronto General Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

08-0512-CE

Identifier Type: -

Identifier Source: org_study_id