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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

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Definity
medical chart review
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ovarian Cancer focused on measuring ovarian germ cell tumor, ovarian epithelial cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt-Ingram Cancer Center - Cool Springs
  • Vanderbilt-Ingram Cancer Center at Franklin
  • Vanderbilt-Ingram Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Definity

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 28, 2008
Last Updated
April 14, 2017
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00626873
Brief Title
Contrast-Enhanced Ultrasonography in Diagnosing Early-Stage Ovarian Cancer in Patients With an Adnexal Mass Undergoing Surgery to Remove the Ovary
Official Title
Microvascular Perfusion Sonographic Imaging to Detect Early Stage Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
ovarian germ cell tumor, ovarian epithelial cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Definity
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Definity
Other Intervention Name(s)
perflutren lipid microspheres
Intervention Description
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
Other
Intervention Name(s)
medical chart review
Primary Outcome Measure Information:
Title
Ovarian microvascularity
Description
To evaluate the use of contrast agents to depict the tumor microvascularity to detect ovarian cancer.
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur C. Fleischer, MD
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David Fishman, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt-Ingram Cancer Center - Cool Springs
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center at Franklin
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22619674
Citation
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.
Results Reference
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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

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