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

NCT00626873 | Completed Phase 1 FDA Drug

• 5 other identifiers: GCO 09-0226P30CA068485VU-VICC-GYN-0720VU-VICC-061292CDR0000584233
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 3

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.

Conditions

Ovarian Cancer

Keywords

ovarian germ cell tumor; ovarian epithelial cancer

Outcome Measures

Primary Outcomes (1)

• Ovarian microvascularity

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

  2 years

Study Arms (1)

Definity

EXPERIMENTAL

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.

Drug: Definity; Other: medical chart review

Interventions

Definity DRUG

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.

Also known as: perflutren lipid microspheres

Definity

medical chart review OTHER

Definity

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Related Publications (1)

• 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.

  PMID: 22619674 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

perflutren

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Arthur C. Fleischer, MD

  Vanderbilt-Ingram Cancer Center

  STUDY CHAIR

• David Fishman, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Obstetrics, Gynecology and Reproductive Science, Director- Gynecologic Oncology Fellowship and National Ovarian Cancer Early Detection Program

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: February 29, 2008
• Study Start: January 1, 2007
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 18, 2017

Record last verified: 2008-10

Locations

US (3)