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Breast MRI Screening in Women Treated With Mediastinal Irradiation for Hodgkin's Disease

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ClinicalTrials.gov Identifier: NCT00165412
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : August 14, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine if the use of breast MRI in detecting breast malignancies in survivors of Hodgkin's disease is more successful than the traditional mammogram.

Condition or disease Intervention/treatment
Breast Cancer Hodgkin's Disease Procedure: breast MRI Procedure: Mammogram

Detailed Description:
  • The screening breast MRI and mammography will be performed 6 months or longer after the last mammogram. For pre-menopausal women, the screening will be performed during the second week of the menstrual cycle to reduce cycle-related breast changes. As much as possible, the breast MRI and mammogram are to be performed on the same day.
  • On the day of the breast imaging studies, the patient will also be asked to fill out a baseline breast health questionnaire, which includes questions on time since radiation therapy, prior screening history, history of prior benign breast biopsies, menopausal status, prior hormonal therapy use, etc.
  • In patients with suspicious findings or findings highly suggestive of malignancy, the abnormal findings will be reviewed with the patient and recommendations will be made for a biopsy.

Study Design

Study Type : Observational
Estimated Enrollment : 168 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Breast MRI Screening in Women Treated With Mediastinal Irradiation for Hodgkin's Disease
Study Start Date : July 2005
Primary Completion Date : May 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Procedure: breast MRI
    Repeated once a year for three years
    Procedure: Mammogram
    Repeated once a year for three years

Outcome Measures

Primary Outcome Measures :
  1. To compare the sensitivity, specificity, positive and negative predictive value of mammography and breast MRI for breast cancer detection in women treated for Hodgkin's disease. [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. To describe the MRI appearance and enhancing characteristics of breast cancer after Hodgkin's disease [ Time Frame: 5 years ]
  2. to correlate the breast MRI findings and pathological findings [ Time Frame: 5 years ]
  3. to determine the incidence of interval breast cancer in the screened population. [ Time Frame: 5 years ]

Eligibility Criteria

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Survivors of Hodgkin's disease that have been previously received radiation therapy to the chest area

Inclusion Criteria:

  • Female patients treated with radiation therapy to the chest area for Hodgkin's disease
  • Age between 12 and 35 at initial treatment
  • Eight years or longer after initial treatment
  • Pre-approval from the participant's insurance company for the breast imaging studies

Exclusion Criteria:

  • Pregnant or lactating women
  • Post Bilateral mastectomy
  • Currently undergoing breast cancer therapy
  • Known metastatic cancer
  • Patients with contraindications for undergoing an MRI: cardiac pacemaker, known metallic objects in body e.g. metallic clips, bullets, shrapnel or buckshots.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165412

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Center
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Principal Investigator: Andrea K. Ng, MD Dana-Farber Cancer Institute
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrea K. Ng, MD, Radiation Oncologist, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00165412     History of Changes
Other Study ID Numbers: 05-241
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: August 14, 2012
Last Verified: August 2012

Keywords provided by Andrea K. Ng, MD, Dana-Farber Cancer Institute:
Breast screening
Breast MRI

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases