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



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

For Condition: stage 3A breast cancer,stage 3B breast cancer,stage 1 breast cancer,stage 2 breast cancer,inflammatory breast cancer
Status: No longer recruiting
Sponsor(s): Royal Marsden NHS Trust ,
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type:
  Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
GeraldGui,  Study Chair,  Royal Marsden NHS Trust

Royal Marsden NHS Trust
London,  England,  SW3 6JJ
United Kingdom
 


Additional Information:
Study ID Numbers:
  CDR0000067655;  RMNHS-1443,EU-20003
Study Start Date: August 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005058

Other Stage 1 Breast Cancer Studies:
1. MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer

2. Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer

3. Epoetin Alfa in Treating Chemotherapy-Related Anemia in Women With Stage I, Stage II, or Stage III Breast Cancer

4. Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer

5. Cryosurgery in Treating Women With Breast Lesions

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