Breast Cancer, Hodgkin's Disease
Conditions
Keywords
Breast screening, Breast MRI, Mammogram, Mammography
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.
Interventions
PROCEDUREbreast MRI
Repeated once a year for three years
PROCEDUREMammogram
Repeated once a year for three years
Sponsors
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed