X-Ray Mammography Standard of Care Protocol

June 30, 2017 updated by: National Institutes of Health Clinical Center (CC)

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

  • INCLUSION CRITERIA:

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

  1. All women who fall under the ACS mammography guidelines

  2. Women younger than 40 years but with more than 20% lifetime risk for developing breast cancer:

    1. Prior personal history of prior thoracic radiation therapy between the age of 10 and 30, such as for Hodgkin's disease. In this case, women are eligible beginning 8-10 years after radiotherapy or at age 40, whichever comes first.
    2. 5-year risk of invasive breast cancer (greater than or equal to 1.7% of women greater than or equal to 35 years or women who have a life time risk greater than 20% as defined by models that are largely dependent on family history.
    3. Strong family history;

    i. First degree relative diagnosed with breast, ovarian, fallopian tube, or primary peritoneal cancer.

    ii. Individual from families known to have BRCA 1 or 2 gene mutation.

    iii. Close male blood relative with breast cancer.

    d. Genetic predisposition;

    i. Carry or have first-degree relative who carries a genetic mutation in the BRCA 1 or 2 genes.

    ii. Carry or have a first-degree relative who carries a genetic mutation in the TP53 or PTEN genes (Li-Fraumeni syndrome and Cowden Bannayan-Riley-Ruvalcaba syndromes).

    e. A personal history of Lobular carcinoma in situ (LCIS) and/or atypical ductal hyperplasia (ADH)

    f. Prior personal history of breast cancer or ovarian cancer.

    i. Starting at the age of 25 year for Hereditary breast and ovarian cancer patients.

    ii. 5-10 years prior to youngest breast cancer case for strong family history or other genetic predisposition.

    g. Woman and Minorities

    EXCLUSION CRITERIA:

    Pregnant or lactating subjects.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institutes of Health Clinical Center (CC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 30, 2009

Study Completion

September 20, 2011

Study Registration Dates

First Submitted

January 16, 2010

First Submitted That Met QC Criteria

January 16, 2010

First Posted (Estimate)

January 20, 2010

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

September 20, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100042
  • 10-CC-0042

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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