Breast MRI Screening in Women Treated With Mediastinal Irradiation for Hodgkin's Disease - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital Beth Israel Deaconess Medical Center
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00165412

Purpose

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.

Condition	Intervention
Breast Cancer Hodgkin's Disease	Procedure: breast MRI Procedure: Mammogram

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Hodgkin's Disease Mammography Radiation Therapy

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Breast MRI Screening in Women Treated With Mediastinal Irradiation for Hodgkin's Disease

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

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. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To describe the MRI appearance and enhancing characteristics of breast cancer after Hodgkin's disease [ Time Frame: 5 years ] [ Designated as safety issue: No ]
to correlate the breast MRI findings and pathological findings [ Time Frame: 5 years ] [ Designated as safety issue: No ]
to determine the incidence of interval breast cancer in the screened population. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	168
Study Start Date:	July 2005
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Repeated once a year for three years

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Survivors of Hodgkin's disease that have been previously received radiation therapy to the chest area

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165412

Contacts

Contact: Andrea K. Ng, MD

617-632-7361

andrea_ng@dfci.harvard.edu

Locations

United States, Massachusetts
Dana-Farber Cancer Center	Recruiting
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Brigham and Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator:

Andrea K. Ng, MD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Dana-Farber Cancer Institute/Brigham and Women's Hospital ( Andrea Ng, MD )
Study ID Numbers:	05-241
Study First Received:	September 9, 2005
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00165412 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Breast screening
Breast MRI
Mammogram
Mammography

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Skin Diseases
Hodgkin Lymphoma, Adult
Hodgkin's Disease

Breast Neoplasms
Lymphoproliferative Disorders
Lymphoma
Hodgkin Disease
Breast Diseases

Additional relevant MeSH terms:

Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms by Site
Immune System Diseases

Skin Diseases
Breast Neoplasms
Lymphoproliferative Disorders
Lymphoma
Hodgkin Disease
Breast Diseases

ClinicalTrials.gov processed this record on May 06, 2009