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

NCT00531570 | Completed

• 1 other identifier: NYU 04-31 H11941
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Neoplasms

Keywords

Women with ultrasound defined complex pelvic masses

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Known or suspected hypersensitivity to blood, blood products, or albumin.
• Known history of congenital heart defect that creates a bi-directional or right-to-left shunt.
• Known history of severe emphysema or a history of pulmonary emboli.
• known history of severe pulmonary hypertension (systolic pulmonary artery pressures \> 90 mmHg).

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Cancer Institute

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• David Fishman, M.D.

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 18, 2007
• First Posted: September 19, 2007
• Study Start: February 1, 2005
• Study Completion: April 1, 2009
• Last Updated: September 23, 2010

Record last verified: 2010-09

Locations

US (1)