Breast MRI and Mammogram in Breast Cancer and Hodgkin's Disease - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

148

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome 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. Time Frame: 5 years	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
To describe the MRI appearance and enhancing characteristics of breast cancer after Hodgkin's disease Time Frame: 5 years	5 years
to correlate the breast MRI findings and pathological findings Time Frame: 5 years	5 years
to determine the incidence of interval breast cancer in the screened population. Time Frame: 5 years	5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Beth Israel Deaconess Medical Center

Brigham and Women's Hospital

Investigators

Principal Investigator: Andrea K. Ng, MD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Ng AK, Garber JE, Diller LR, Birdwell RL, Feng Y, Neuberg DS, Silver B, Fisher DC, Marcus KJ, Mauch PM. Prospective study of the efficacy of breast magnetic resonance imaging and mammographic screening in survivors of Hodgkin lymphoma. J Clin Oncol. 2013 Jun 20;31(18):2282-8. doi: 10.1200/JCO.2012.46.5732. Epub 2013 Apr 22.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria