Efficacy of Ultrasound Contrast Agent to Assess Renal Masses

University Health Network, Toronto

Status and phase: Completed; Phase 2

Conditions: Renal Cell Carcinoma

Treatments: Drug: Definity

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01062178

08-0512-CE

Details and patient eligibility

About

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.

Enrollment: 167 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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167 participants in 1 patient group

comparison to biopsy

Experimental group

Description:

Comparing contrast enhanced US with biopsy result

Treatment:

Drug: Definity