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

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Andrea K. Ng, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00165412
First received: September 9, 2005
Last updated: August 13, 2012
Last verified: August 2012
  Purpose

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 Intervention
Breast Cancer
Hodgkin's Disease
Procedure: breast MRI
Procedure: Mammogram

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Breast MRI Screening in Women Treated With Mediastinal Irradiation for Hodgkin's Disease

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe the MRI appearance and enhancing characteristics of breast cancer after Hodgkin's disease [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • to correlate the breast MRI findings and pathological findings [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • to determine the incidence of interval breast cancer in the screened population. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 168
Study Start Date: July 2005
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: breast MRI
    Repeated once a year for three years
    Procedure: Mammogram
    Repeated once a year for three years
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.
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders 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

Criteria

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
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: NCT00165412

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

No publications provided by Dana-Farber Cancer Institute

Additional 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
Study First Received: September 9, 2005
Last Updated: August 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Breast screening
Breast MRI
Mammogram
Mammography

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

ClinicalTrials.gov processed this record on September 22, 2014