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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00626873
First received: February 28, 2008
Last updated: August 11, 2009
Last verified: October 2008
  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
Ovarian Cancer
Drug: perflutren lipid microspheres
Other: medical chart review

Study Type: Interventional
Study Design: Masking: 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 National Cancer Institute (NCI):

Primary Outcome Measures:
  • Ovarian microvascularity [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2007
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   21 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626873

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center    800-811-8480      
Vanderbilt-Ingram Cancer Center - Cool Springs Recruiting
Nashville, Tennessee, United States, 37064
Contact: Arthur Fleischer    615-322-2826      
Vanderbilt-Ingram Cancer Center at Franklin Recruiting
Nashville, Tennessee, United States, 37064
Contact: Arthur Fleischer    615-322-2826      
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Study Chair: Arthur C. Fleischer, MD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00626873     History of Changes
Other Study ID Numbers: CDR0000584233, VU-VICC-GYN-0720, VU-VICC-061292
Study First Received: February 28, 2008
Last Updated: August 11, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
ovarian germ cell tumor
ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Definity
Perflutren
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2014