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Microvascular Perfusion Sonographic Imaging to Detect Early Stage Ovarian Cancer


N/A
21 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

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Trial Information

Microvascular Perfusion Sonographic Imaging to Detect Early Stage Ovarian Cancer


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Ovarian microvascularity

Safety Issue:

No

Principal Investigator

Arthur C. Fleischer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

Unspecified

Study ID:

CDR0000584233

NCT ID:

NCT00626873

Start Date:

January 2007

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • ovarian germ cell tumor
  • ovarian epithelial cancer
  • Ovarian Neoplasms

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Vanderbilt-Ingram Cancer Center - Cool SpringsNashville, Tennessee  37064
Vanderbilt-Ingram Cancer Center at FranklinNashville, Tennessee  37064