X-Ray Mammography Standard of Care Protocol

Breast Cancer Clinical Trial

Official title: X-Ray Mammography Standard of Care Protocol

Status Completed

Clinical Trial Summary

Background:

• X-ray mammography is the standard method for breast cancer screening. It is a noninvasive test using x-rays to take pictures of breast tissue and detect any abnormalities.

• The National Institutes of Health (NIH) Clinical Center has a breast imaging unit that has been accredited by the American College of Radiology. To maintain accreditation, the unit must recruit a certain number of women to have clinical mammograms each year in order to maintain a high level of clinical skills and experience for the radiologists and technologists.

Objectives:

• To create a state-of-the-art mammography unit at the NIH Clinical Center in order to maintain American College of Radiology accreditation of the NIH breast imaging facility.

Eligibility:

• Women who are eligible for breast cancer screening because of family cancer history, genetic test results, or previous instances of cancer. Participants may not be pregnant or nursing at the time of the screening.

Design:

• Participants will provide a brief medical history on arrival at the NIH breast imaging unit.

• Each participant will have a standard mammogram performed by a radiology technician.

• If the study is normal, participants will be told that no further evaluation will be performed. If the results indicate a need for further imaging or tissue biopsy, participants may elect to return to the care of their primary physician or to receive further follow-up at the NIH Clinical Center.

Clinical Trial Description

Background:

A mammography facility in the Clinical Center of the National Institutes of Health (NIH) is present in order to facilitate breast cancer research programs. The American College of Radiology mammography accreditation program (1992 mammography Quality Standards Act (MQSA) (1-3)) has established national standards for site accreditation for mammography. A key requirement is to perform a minimum number of mammography examinations in the facility per year. Minimum examination volumes are required to maintain expertise of the facility staff for maintaining facility accreditation and compliance with Food and Drug Administration (FDA) requirements.

Objectives:

Our primary aim is a protocol to maintain accreditation of the NIH breast imaging facility in the Clinical Center of NIH.

Eligibility:

Women who are clinically indicated for screening mammography according to the National Comprehensive Cancer Network (NCCN) guidelines (3) and the American Cancer Society guidelines.

Design:

A standard of care protocol to perform standard clinically indicated mammography exams. We are expected to recruit 1000 patient /year. ;

Related Conditions & MeSH terms

• Atypical Ductal Hyperplasia
• Breast Cancer
• Carcinoma
• Carcinoma in Situ
• Fibrocystic Changes
• Hyperplasia
• In Situ Carcinoma
• Invasive Carcinoma

• NCT number: NCT01052740
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Phase: N/A
• Start date: December 30, 2009
• Completion date: September 20, 2011