Enhanced Ultrasound in Determining Extent of Disease in Women With Primary Breast Cancer
Recruitment status was Active, not recruiting
|First Received Date ICMJE||April 6, 2000|
|Last Updated Date||November 5, 2013|
|Start Date ICMJE||August 1997|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00005058 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|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|
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.
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 Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Primary Purpose: Diagnostic|
|Condition ICMJE||Breast Cancer|
|Intervention ICMJE||Procedure: ultrasound imaging|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Enrollment ICMJE||Not Provided|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|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
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United Kingdom|
|NCT Number ICMJE||NCT00005058|
|Other Study ID Numbers ICMJE||CDR0000067655, RMNHS-1443, EU-20003|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Royal Marsden NHS Foundation Trust|
|Collaborators ICMJE||Not Provided|
|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