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


N/A
20 Years
N/A
Not Enrolling
Female
Breast Cancer, Hodgkin's Disease

Thank you

Trial Information

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


- 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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Andrea K. Ng, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

05-241

NCT ID:

NCT00165412

Start Date:

July 2005

Completion Date:

May 2010

Related Keywords:

  • Breast Cancer
  • Hodgkin's Disease
  • Breast screening
  • Breast MRI
  • Mammogram
  • Mammography
  • Breast Neoplasms
  • Hodgkin Disease

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Brigham and Women's HospitalBoston, Massachusetts  02115
Dana-Farber Cancer CenterBoston, Massachusetts  02115