Efficacy of Ultrasound Contrast Agent to Assess Renal Masses

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01062178

Enrollment

167

Registered

2010-02-04

Start date

2009-10-31

Completion date

2012-12-31

Last updated

2016-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cell Carcinoma

Keywords

Small renal Mass, Contrast Enhanced Ultrasound, Renal Cell Carcinoma, noninvasive diagnosis of RCC

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.

Interventions

DRUGDefinity

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
biopsy	12 to 18 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026