Contrast-Enhanced Ultrasonography in Diagnosing Early-Stage Ovarian Cancer in Patients With an Adnexal Mass Undergoing Surgery to Remove the Ovary

Phase 1

Completed

• Conditions: Ovarian Cancer
• Interventions: Drug: Definity; Other: medical chart review

• Registration Number: NCT00626873
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

RATIONALE: New diagnostic procedures, such as contrast-enhanced ultrasonography, may be an effective method of finding ovarian cancer.

PURPOSE: This clinical trial is studying how well contrast-enhanced ultrasonography works in diagnosing early-stage ovarian cancer in patients with an adnexal mass undergoing surgery to remove the ovary.

Detailed Description

OBJECTIVES:

* Determine whether use of a contrast agent improves the images of the ovaries during ultrasonography.

OUTLINE: This is a multicenter study.

Patients may undergo baseline transabdominal or transvaginal ultrasonography, if not already done. Patients then undergo contrast-enhanced transabdominal or transvaginal ultrasonography using perflutren lipid microspheres (Definity®) IV.

Pathology reports from tissue collected during subsequent oophorectomy is analyzed and compared with ultrasonography findings.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-02-28
• Study First Submitted QC: 2008-02-28
• Study First Posted: 2008-02-29
• Status Verified: 2008-10
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Last Update Submitted: 2017-04-14
• Last Update Posted: 2017-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 67

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Definity	medical chart review	Definity - perflutren lipid microspheres, 1-10 microns in diameter, which is approved for the use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border, to enhance the visualization of the ovarian vascular system.
Definity	Definity	Definity - perflutren lipid microspheres, 1-10 microns in diameter, which is approved for the use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border, to enhance the visualization of the ovarian vascular system.

Primary Outcome Measures

Name	Time	Method
Ovarian microvascularity	2 years	To evaluate the use of contrast agents to depict the tumor microvascularity to detect ovarian cancer.

Trial Locations

Locations (3)

Vanderbilt-Ingram Cancer Center at Franklin; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center - Cool Springs; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States