Enhanced Ultrasound in Determining Extent of Disease in Women With Primary Breast Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

April 6, 2000

Last Updated Date

February 6, 2009

Start Date ^ICMJE

August 1997

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00005058 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Enhanced Ultrasound in Determining Extent of Disease in Women With Primary Breast Cancer

Official Title ^ICMJE

A Direct Comparison of Contrast Enhanced Power Doppler Ultrasound in Primary Breast Cancer and Axillary Nodal Status With Histopathological Variables and Clinical Outcome

Brief Summary

RATIONALE: New imaging procedures, such as enhanced ultrasound may improve the ability to determine the extent of breast cancer.

PURPOSE: Diagnostic study of enhanced ultrasound in women who have locally advanced primary breast cancer.

Detailed Description

OBJECTIVES: I. Measure blood flow of primary breast lesions and corresponding lymph nodes by Power Doppler Ultrasound (PDU) and compare this information with metastatic potential and patient survival in women with primary breast cancer. II. Correlate intratumor/-nodal blood flow with pathological variables using standard histology and special stains in this patient population. III. Correlate intratumor microvessel density with total tumor blood flow and with the presence of axillary lymph node metastases using this diagnostic method in these patients. IV. Correlate tumor blood flow with various markers of angiogenesis using this diagnostic method in these patients. V. Compare tumor blood flow as measured with PDU before and after contrast enhancement in these patients.

OUTLINE: This is a diagnostic study. Patients receive ultrasound contrast agent IV. An ultrasound probe with Power Doppler facility is swept over the skin surface in a standard fashion before and after contrast enhancement. Blood flow data is acquired over the volume of the mass and/or lymph nodes using a video recorder. The scanning time ranges between 5 to 15 minutes depending on the size and exact location of the breast mass and axillary lymph nodes. Within 1 week of the ultrasound, patients undergo surgery and the mass and axillary lymph nodes are removed.

PROJECTED ACCRUAL: Approximately 200 patients will be accrued for this study within 1 year.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Procedure: ultrasound imaging

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS: Clinically suspected locally advanced breast cancer where treatment indicated is primary surgery (wide local excision or simple mastectomy) and axillary dissection (clearance) Inflammatory breast cancer eligible No recurrent disease Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No New York Heart Association class III or IV heart disease At least 14 days since prior myocardial infarction Pulmonary: No severe chronic obstructive pulmonary disease Other: No galactosemia No mental illness or handicap

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior neoadjuvant chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics At least 1 month since prior core biopsy (Tru-cut) of breast cancer

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00005058

Responsible Party

Study ID Numbers ^ICMJE

CDR0000067655, RMNHS-1443, EU-20003

Study Sponsor ^ICMJE

Royal Marsden - London

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng)

Royal Marsden - London

Information Provided By

National Cancer Institute (NCI)

Verification Date

April 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP