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Microvascular Ultrasonographic Imaging for the Detection of Early Stage Epithelial Ovarian Carcinoma
This study is currently recruiting participants.
Verified by New York University School of Medicine, May 2008
Sponsored by: New York University School of Medicine
Information provided by: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00531570
  Purpose

In the United States, ovarian cancer is the fifth most common cancer to develop in women and causes more deaths than all other gynecologic malignancies combined. Because of the difficulties in detecting early stage ovarian cancer, 75% of women continue to be diagnosed with advanced stage disease (stage III or IV).

The National Ovarian Cancer Early Detection Program (NOCEDP) as part of the National Cancer Institute's Early Detection Research Network (EDRN) is committed to the development of effective means for the accurate detection of early stage ovarian cancer.

The last decade has seen rapid technological advances in diagnostic ultrasonography with the recent development of three-dimensional imaging.

Initial studies suggest that these new technologies improve upon the diagnostic accuracy of two-dimensional transvaginal imaging in the differentiation between benign and malignant pathology.

This improved diagnostic accuracy may promote improved patient care by separating complex benign masses from ovarian cancer therefore facilitating appropriate treatment.


Condition
Ovarian Neoplasms

MedlinePlus related topics: Cancer Ovarian Cancer Ultrasound
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Microvascular Ultrasonographic Imaging for the Detection of Early Stage Epithelial Ovarian Carcinoma

Further study details as provided by New York University School of Medicine:

Estimated Enrollment: 100
Study Start Date: February 2005
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women must be greater than 21 years of age
  2. Women must have a complex adnexal mass (as defined per ultrasound) which requires surgical intervention

Exclusion Criteria:

  1. Known or suspected hypersensitivity to blood, blood products, or albumin.
  2. Known history of congenital heart defect that creates a bi-directional or right-to-left shunt.
  3. Known history of severe emphysema or a history of pulmonary emboli.
  4. known history of severe pulmonary hypertension (systolic pulmonary artery pressures > 90 mmHg).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00531570

Contacts
Contact: David Fishman, M.D. 212-263-7141 david.fishman@med.nyu.edu
Contact: Louise Lynch, R.N. 212-731-5405 louise.lynch@nyumc.org

Locations
United States, New York
NYU Cancer Institute Recruiting
New York, New York, United States, 10016
Contact: David Fishman, M.D.     212-263-7141     david.fishman@med.nyu.edu    
Contact: Louise Lynch, R.N.     212-731-5405     louise.lynch@nyumc.org    
Principal Investigator: David Fishman, M.D.            
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: David Fishman, M.D. New York University School of Medicine
  More Information

Responsible Party: New York University School of Medicine ( David Fishman, M.D. )
Study ID Numbers: NYU 04-31 H11941
Study First Received: September 18, 2007
Last Updated: May 21, 2008
ClinicalTrials.gov Identifier: NCT00531570  
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
Women with ultrasound defined complex pelvic masses

Study placed in the following topic categories:
Genital Diseases, Female
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Ovarian epithelial cancer
Endocrine Gland Neoplasms
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009