Clinical trial NCT00626873: Contrast-Enhanced Ultrasonography in Diagnosing Early-Stage Ovarian Cancer in Patients With an Adnexal Mass Undergoing Surgery to Remove the Ovary
Official title: Microvascular Perfusion Sonographic Imaging to Detect Early Stage Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ovarian Cancer
Keywords: ovarian germ cell tumor
ovarian epithelial cancer
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-02-29
Enrollment: 67
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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 criteria: 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

Primary outcomes:
measure: Ovarian microvascularity
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center - Cool Springs
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center at Franklin
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Arthur C. Fleischer, MD
role: STUDY_CHAIR
affiliation: Icahn School of Medicine at Mount Sinai
name: David Fishman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fleischer AC, Lyshchik A, Hirari M, Moore RD, Abramson RG, Fishman DA. Early detection of ovarian cancer with conventional and contrast-enhanced transvaginal sonography: recent advances and potential improvements. J Oncol. 2012;2012:302858. doi: 10.1155/2012/302858. Epub 2012 Apr 26.