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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-02-28

Study Completion Date

2009-04-30

Brief Summary

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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

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Conditions

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Ovarian Neoplasms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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New York University School of Medicine

Principal Investigators

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David Fishman, M.D.

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Cancer Institute

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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NYU 04-31 H11941

Identifier Type: -

Identifier Source: org_study_id