Full Text View
Tabular View
No Study Results Posted
Related Studies
Enhanced Ultrasound in Determining Extent of Disease in Women With Primary Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: April 6, 2000   Last Updated: February 6, 2009   History of Changes
Sponsored by: Royal Marsden - London
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005058
  Purpose

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.


Condition Intervention
Breast Cancer
Procedure: ultrasound imaging

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Ultrasound
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic
Official Title: A Direct Comparison of Contrast Enhanced Power Doppler Ultrasound in Primary Breast Cancer and Axillary Nodal Status With Histopathological Variables and Clinical Outcome

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 1997
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005058

Locations
United Kingdom, England
Royal Marsden NHS Trust
London, England, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Royal Marsden - London
Investigators
Study Chair: Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng) Royal Marsden - London
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067655, RMNHS-1443, EU-20003
Study First Received: April 6, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00005058     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
inflammatory breast cancer

Study placed in the following topic categories:
Inflammatory Breast Cancer
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009