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

NCT00626873CompletedPHASE1INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

67

Start Date

2007-01-01

Completion Date

2012-02-01

Study Type

INTERVENTIONAL

Official Title

Microvascular Perfusion Sonographic Imaging to Detect Early Stage Ovarian Cancer

Interventions

Definitymedical chart review

Conditions

Ovarian Cancer

Eligibility

Age Range

21 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Ovarian microvascularity

To evaluate the use of contrast agents to depict the tumor microvascularity to detect ovarian cancer.

Time frame: 2 years

Locations

Vanderbilt-Ingram Cancer Center - Cool Springs, Nashville, United States

Vanderbilt-Ingram Cancer Center at Franklin, Nashville, United States

Vanderbilt-Ingram Cancer Center, Nashville, United States

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