Contrast-Enhanced Ultrasonography in Diagnosing Early-Stage Ovarian Cancer in Patients With an Adnexal Mass Undergoing Surgery to Remove the Ovary



Status:Recruiting
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - Any
Updated:4/2/2016
Start Date:January 2007

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Microvascular Perfusion Sonographic Imaging to Detect Early Stage Ovarian Cancer

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.

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.

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
We found this trial at
3
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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324 Cool Springs Blvd
Nashville, Tennessee 37067
(877) 936-8422
Vanderbilt-Ingram Cancer Center - Cool Springs Vanderbilt-Ingram Cancer Center Cool Springs is a medical oncology...
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Nashville, TN
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2107 Edward Curd Lane
Nashville, Tennessee 37067
615-591-9890
Vanderbilt-Ingram Cancer Center at Franklin The Vanderbilt-Ingram Cancer Center at Franklin is a free-standing radiation...
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Nashville, TN
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