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Sponsors and Collaborators: |
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00626873 |
RATIONALE: New diagnostic procedures, such as contrast-enhanced ultrasonography, may be an effective method of finding ovarian cancer.
PURPOSE: This clinical trial is studying how well contrast-enhanced ultrasonography works in diagnosing early-stage ovarian cancer in patients with an adnexal mass undergoing surgery to remove the ovary.
Condition | Intervention |
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Ovarian Cancer |
Drug: perflutren lipid microspheres Procedure: medical chart review |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label |
Official Title: | Microvascular Perfusion Sonographic Imaging to Detect Early Stage Ovarian Cancer |
Estimated Enrollment: | 100 |
Study Start Date: | January 2007 |
Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients may undergo baseline transabdominal or transvaginal ultrasonography, if not already done. Patients then undergo contrast-enhanced transabdominal or transvaginal ultrasonography using perflutren lipid microspheres (Definity®) IV.
Pathology reports from tissue collected during subsequent oophorectomy is analyzed and compared with ultrasonography findings.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center - Cool Springs | Recruiting |
Nashville, Tennessee, United States, 37064 | |
Contact: Arthur Fleischer 615-322-2826 | |
Vanderbilt-Ingram Cancer Center at Franklin | Recruiting |
Nashville, Tennessee, United States, 37064 | |
Contact: Arthur Fleischer 615-322-2826 | |
Vanderbilt-Ingram Cancer Center | Recruiting |
Nashville, Tennessee, United States, 37232-6838 | |
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 |
Study Chair: | Arthur C. Fleischer, MD | Vanderbilt-Ingram Cancer Center |
Study ID Numbers: | CDR0000584233, VU-VICC-GYN-0720, VU-VICC-061292 |
Study First Received: | February 28, 2008 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00626873 |
Health Authority: | Unspecified |
ovarian germ cell tumor ovarian epithelial cancer |
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 |
Neoplasms Neoplasms by Site Adnexal Diseases |