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

• Sponsor: Icahn School of Medicine at Mount Sinai (Other)
• Overall Status: Completed
• CT.gov ID: NCT00626873
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 67
• Locations: 3
• Arm: 1
• Duration (Months): 61
• Patients Per Site: 22.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer	Drug: Definity; Other: medical chart review	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 67 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Microvascular Perfusion Sonographic Imaging to Detect Early Stage Ovarian Cancer
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

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 Names: perflutren lipid microspheres ; Other: medical chart review

Outcome Measures

Primary Outcome Measures

1. Ovarian microvascularity [2 years]

   To evaluate the use of contrast agents to depict the tumor microvascularity to detect ovarian cancer.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee	United States	37064
2	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee	United States	37064
3	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232-6838

Sponsors and Collaborators

• Icahn School of Medicine at Mount Sinai
• National Cancer Institute (NCI)

Investigators

• Study Chair: Arthur C. Fleischer, MD, Vanderbilt-Ingram Cancer Center
• Principal Investigator: David Fishman, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David Fishman, Professor Obstetrics, Gynecology and Reproductive Science, Director- Gynecologic Oncology Fellowship and National Ovarian Cancer Early Detection Program, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT00626873
• Other Study ID Numbers: GCO 09-0226; P30CA068485; VU-VICC-GYN-0720; VU-VICC-061292; CDR0000584233
• First Posted: Feb 29, 2008
• Last Update Posted: Apr 18, 2017
• Last Verified: Oct 1, 2008

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by David Fishman, Professor Obstetrics, Gynecology and Reproductive Science, Director- Gynecologic Oncology Fellowship and National Ovarian Cancer Early Detection Program, Icahn School of Medicine at Mount Sinai: ovarian germ cell tumor; ovarian epithelial cancer
• Additional relevant MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Study Results

No Results Posted as of Apr 18, 2017