X-Ray Mammography Standard of Care Protocol

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01052740
First received: January 16, 2010
Last updated: September 23, 2011
Last verified: September 2011
  Purpose

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.

Condition
Breast Cancer
Invasive Carcinoma
In Situ Carcinoma
Fibrocystic Changes
Atypical Ductal Hyperplasia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: X-Ray Mammography Standard of Care Protocol

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 108
Study Start Date: December 2009
Estimated Study Completion Date: September 2011
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.

  Eligibility

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052740

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01052740     History of Changes
Other Study ID Numbers: 100042, 10-CC-0042
Study First Received: January 16, 2010
Last Updated: September 23, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Breast Cancer
Mammography
Screening

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma in Situ
Hyperplasia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014