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

Completed

• Conditions: Breast Cancer; Hodgkin's Disease

• Registration Number: NCT00165412
• Lead Sponsor: Dana-Farber Cancer Institute

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-14
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-30
• Last Update Posted: 2019-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 148

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (3)

Dana-Farber Cancer Center; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States