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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai; Vanderbilt-Ingram Cancer Center
• Collaborator: National Cancer Institute (NCI)

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