Contrast-Enhanced Ultrasonography in Diagnosing Early-Stage Ovarian Cancer in Patients With an Adnexal Mass Undergoing Surgery to Remove the Ovary
Recruitment status was Recruiting
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Purpose
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 |
|---|---|
|
Ovarian Cancer |
Drug: perflutren lipid microspheres Other: medical chart review |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Microvascular Perfusion Sonographic Imaging to Detect Early Stage Ovarian Cancer |
- Ovarian microvascularity [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2007 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine whether use of a contrast agent improves the images of the ovaries during ultrasonography.
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Diagnosis of adnexal mass
- Scheduled to undergo surgical oophorectomy
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Negative pregnancy test
- No known respiratory failure as manifested by signs and symptoms of carbon dioxide retention or hypoxemia
- No pulmonary vasculitis
- No known history of severe emphysema
- No known history of pulmonary emboli
- No other condition that causes pulmonary hypertension due to compromised pulmonary arterial vasculature
- No known history of severe pulmonary hypertension (i.e., systolic pulmonary artery pressures > 90 mm Hg)
- No known history of congenital heart defect that creates a bidirectional or right-to-left shunt
- No worsening or clinically unstable congestive heart failure
- No known acute myocardial infarction or acute coronary syndromes
- No known serious ventricular arrhythmias
- Not at high risk for arrhythmia due to prolongation of the QT interval
- No known or suspected hypersensitivity to blood, blood products, or albumin
- No known hypersensitivity to perflutren
- No known or suspected hypersensitivity to octafluoropropane or any other ingredients of perflutren lipid microspheres (Definity®)
- No mental status problems, illiteracy, or other circumstance that would preclude giving informed consent
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00626873 History of Changes |
| Other Study ID Numbers: | CDR0000584233, VU-VICC-GYN-0720, VU-VICC-061292 |
| Study First Received: | February 28, 2008 |
| Last Updated: | August 11, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
ovarian germ cell tumor ovarian epithelial cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
ClinicalTrials.gov processed this record on May 16, 2013