Clinical trial NCT00165412: Breast MRI Screening in Women Treated With Mediastinal Irradiation for Hodgkin's Disease
Official title: Breast MRI Screening in Women Treated With Mediastinal Irradiation for Hodgkin's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Hodgkin's Disease
Keywords: Breast screening
Breast MRI
Mammogram
Mammography
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Beth Israel Deaconess Medical Center
First posted: 2005-09-14
Enrollment: 148
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Survivors of Hodgkin's disease that have been previously received radiation therapy to the chest area

Brief 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.

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 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.

Primary outcomes:
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.
timeFrame: 5 years
Secondary outcomes:
measure: To describe the MRI appearance and enhancing characteristics of breast cancer after Hodgkin's disease
timeFrame: 5 years
measure: to correlate the breast MRI findings and pathological findings
timeFrame: 5 years
measure: to determine the incidence of interval breast cancer in the screened population.
timeFrame: 5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Andrea K. Ng, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.