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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00626873
First Posted: February 29, 2008
Last Update Posted: April 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David Fishman, Icahn School of Medicine at Mount Sinai
  Purpose

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 Intervention Phase
Ovarian Cancer Drug: Definity Other: medical chart review Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Microvascular Perfusion Sonographic Imaging to Detect Early Stage Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by David Fishman, Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • Ovarian microvascularity [ Time Frame: 2 years ]
    To evaluate the use of contrast agents to depict the tumor microvascularity to detect ovarian cancer.


Enrollment: 67
Study Start Date: January 2007
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: perflutren lipid microspheres
Other: medical chart review

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626873


Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
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
  More Information

Publications:
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     History of Changes
Other Study ID Numbers: GCO 09-0226
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-GYN-0720
VU-VICC-061292
CDR0000584233
First Submitted: February 28, 2008
First Posted: February 29, 2008
Last Update Posted: April 18, 2017
Last Verified: October 2008

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David Fishman, Icahn School of Medicine at Mount Sinai:
ovarian germ cell tumor
ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders