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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Breast Cancer, Hodgkin's Disease

Intervention / Treatment
-----------------
* Procedure: breast MRI
* Procedure: Mammogram


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: breast MRI|Repeated once a year for three years|
|Procedure: Mammogram|Repeated once a year for three years|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast screening, Breast MRI, Mammogram, Mammography