Breast MRI Screening in Women Treated With Mediastinal Irradiation for Hodgkin's Disease
1 other identifier
observational
148
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2005
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedMay 2, 2019
April 1, 2019
4.8 years
September 9, 2005
April 30, 2019
Conditions
Keywords
Outcome Measures
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.
5 years
Secondary Outcomes (3)
To describe the MRI appearance and enhancing characteristics of breast cancer after Hodgkin's disease
5 years
to correlate the breast MRI findings and pathological findings
5 years
to determine the incidence of interval breast cancer in the screened population.
5 years
Interventions
Repeated once a year for three years
Repeated once a year for three years
Eligibility Criteria
Survivors of Hodgkin's disease that have been previously received radiation therapy to the chest area
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Brigham and Women's Hospitalcollaborator
- Beth Israel Deaconess Medical Centercollaborator
Study Sites (3)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Center
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related Publications (1)
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.
PMID: 23610104DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea K. Ng, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Radiation Oncologist
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 14, 2005
Study Start
July 1, 2005
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
May 2, 2019
Record last verified: 2019-04