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

Microvascular Perfusion Sonographic Imaging to Detect Early Stage Ovarian Cancer

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00626873
Enrollment
67
Registered
2008-02-29
Start date
2007-01-31
Completion date
2012-02-29
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

ovarian germ cell tumor, ovarian epithelial cancer

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.

Interventions

DRUGDefinity

Definity - perflutren lipid microspheres, 1-10 microns in diameter, which is approved for the use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border, to enhance the visualization of the ovarian vascular system.

OTHERmedical chart review

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Ovarian microvascularity2 yearsTo evaluate the use of contrast agents to depict the tumor microvascularity to detect ovarian cancer.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026