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

NCT ID: NCT00626873

Last Updated: 2017-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2012-02-29

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Definity

Intervention Type: DRUG

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.

medical chart review

Intervention Type: OTHER

Interventions

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.

Intervention Type: DRUG

medical chart review

Intervention Type: OTHER

Other Intervention Names

perflutren lipid microspheres

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

David Fishman

Professor Obstetrics, Gynecology and Reproductive Science, Director- Gynecologic Oncology Fellowship and National Ovarian Cancer Early Detection Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arthur C. Fleischer, MD

Role: STUDY_CHAIR

Vanderbilt-Ingram Cancer Center

David Fishman, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Countries

United States

References

Fleischer AC, Lyshchik A, Hirari M, Moore RD, Abramson RG, Fishman DA. Early detection of ovarian cancer with conventional and contrast-enhanced transvaginal sonography: recent advances and potential improvements. J Oncol. 2012;2012:302858. doi: 10.1155/2012/302858. Epub 2012 Apr 26.

Reference Type: RESULT

PMID: 22619674 (View on PubMed)

Other Identifiers

P30CA068485

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VU-VICC-GYN-0720

Identifier Type: -

Identifier Source: secondary_id

VU-VICC-061292

Identifier Type: -

Identifier Source: secondary_id

CDR0000584233

Identifier Type: -

Identifier Source: secondary_id

GCO 09-0226

Identifier Type: -

Identifier Source: org_study_id