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Microvascular Ultrasonographic Imaging for the Detection of Early Stage Epithelial Ovarian Carcinoma

This study has been completed.
Sponsor:
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00531570
First received: September 18, 2007
Last updated: September 22, 2010
Last verified: September 2010
History of Changes
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Microvascular Ultrasonographic Imaging for the Detection of Early Stage Epithelial Ovarian Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

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

Estimated Enrollment: 100
Study Start Date: February 2005
Study Completion Date: April 2009
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women must have a complex adnexal mass (as defined per ultrasound) which requires surgical intervention

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

Locations
United States, New York
NYU Cancer Institute
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: David Fishman, M.D. New York University School of Medicine
  More Information

No publications provided

Responsible Party: David Fishman, M.D., New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00531570     History of Changes
Other Study ID Numbers: NYU 04-31 H11941
Study First Received: September 18, 2007
Last Updated: September 22, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
 Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on June 18, 2013