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

Completed

• Conditions: Ovarian Neoplasms

• Registration Number: NCT00531570
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2007-09-18
• Study First Submitted QC: 2007-09-18
• Study First Posted: 2007-09-19
• Study Completion: 2009-04
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-22
• Last Update Posted: 2010-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

NYU Cancer Institute; 🇺🇸 New York, New York, United States