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

Mount Sinai Health System

Status and phase: Completed; Phase 1

Conditions: Ovarian Cancer

Treatments: Other: medical chart review; Drug: Definity

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00626873

CDR0000584233

VU-VICC-GYN-0720

P30CA068485 (U.S. NIH Grant/Contract)

VU-VICC-061292

GCO 09-0226

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Diagnosis of adnexal mass
• Scheduled to undergo surgical oophorectomy

PATIENT CHARACTERISTICS:

• Not pregnant or nursing
• Negative pregnancy test
• No known respiratory failure as manifested by signs and symptoms of carbon dioxide retention or hypoxemia
• No pulmonary vasculitis
• No known history of severe emphysema
• No known history of pulmonary emboli
• No other condition that causes pulmonary hypertension due to compromised pulmonary arterial vasculature
• No known history of severe pulmonary hypertension (i.e., systolic pulmonary artery pressures > 90 mm Hg)
• No known history of congenital heart defect that creates a bidirectional or right-to-left shunt
• No worsening or clinically unstable congestive heart failure
• No known acute myocardial infarction or acute coronary syndromes
• No known serious ventricular arrhythmias
• Not at high risk for arrhythmia due to prolongation of the QT interval
• No known or suspected hypersensitivity to blood, blood products, or albumin
• No known hypersensitivity to perflutren
• No known or suspected hypersensitivity to octafluoropropane or any other ingredients of perflutren lipid microspheres (Definity®)
• No mental status problems, illiteracy, or other circumstance that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

Definity

Experimental group

Description:

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.

Treatment:

Other: medical chart review

Drug: Definity