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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165412
• Other study ID #: 05-241
• Status: Completed
• Start date: July 2005
• Est. completion date: May 2010

Study information

• Verified date: April 2019
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Hodgkin Disease
• Hodgkin's Disease

Intervention

Procedure:
• breast MRI
Repeated once a year for three years
• Mammogram
Repeated once a year for three years

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To describe the MRI appearance and enhancing characteristics of breast cancer after Hodgkin's disease		5 years
Secondary	to correlate the breast MRI findings and pathological findings		5 years
Secondary	to determine the incidence of interval breast cancer in the screened population.		5 years