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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

148 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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* 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.

Conditions

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Breast Cancer Hodgkin's Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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breast MRI

Repeated once a year for three years

Intervention Type PROCEDURE

Mammogram

Repeated once a year for three years

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No