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Completed

NCT Number: NCT00165412

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

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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Key information

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

breast MRI

Procedure

Repeated once a year for three years

Mammogram

Procedure

Repeated once a year for three years

Primary outcomes

  1. 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

Secondary outcomes

  1. To describe the MRI appearance and enhancing characteristics of breast cancer after Hodgkin's disease

    Time frame: 5 years

  2. to correlate the breast MRI findings and pathological findings

    Time frame: 5 years

  3. to determine the incidence of interval breast cancer in the screened population.

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital

Registry information

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Sep 14, 2005
Registry last updated
May 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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