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

Ovarian Cancer Clinical Trial

Official title:

Microvascular Perfusion Sonographic Imaging to Detect Early Stage Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00626873
• Other study ID #: GCO 09-0226
• Secondary ID: P30CA068485VU-VI
• Status: Completed
• Phase: Phase 1
• First received: February 28, 2008
• Last updated: April 14, 2017
• Start date: January 2007
• Est. completion date: February 2012

Study information

• Verified date: October 2008
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• 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.

Other:
• medical chart review

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: 10.1155/2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovarian microvascularity	To evaluate the use of contrast agents to depict the tumor microvascularity to detect ovarian cancer.	2 years