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

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00165412

Collaborator

Brigham and Women's Hospital (Other), Beth Israel Deaconess Medical Center (Other)

148

Enrollment

Locations

Duration (Months)

49.3

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

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	Phase
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

Actual Enrollment :

148 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 :

Jul 1, 2005

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

May 1, 2010

Outcome Measures

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. [5 years]

Secondary Outcome Measures

To describe the MRI appearance and enhancing characteristics of breast cancer after Hodgkin's disease [5 years]
to correlate the breast MRI findings and pathological findings [5 years]
to determine the incidence of interval breast cancer in the screened population. [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
2	Dana-Farber Cancer Center	Boston	Massachusetts	United States	02115
3	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215