Efficacy of Ultrasound Contrast Agent to Assess Renal Masses

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.

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Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Definity

Drug

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

Primary outcomes

biopsy

Time frame: 12 to 18 months

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

Lantheus Medical Imaging

Registry information

Official study 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

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Feb 4, 2010
Registry last updated: Mar 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed