Study Stopped
Low accrual
Breast Magnetic Resonance Imaging (MRI) Screening After Mantle Radiation Therapy
Breast MRI Screening in High-Risk Women After Mantle Radiation Therapy for Lymphoma
1 other identifier
observational
10
1 country
1
Brief Summary
Objectives: The objective of this single-arm, prospective study is to perform annual mammography and MRI breast cancer screening in women who underwent mantle-field irradiation between 1970-1995 at M. D. Anderson Cancer Center in order to compare the ability of MRI and standard mammography to identify breast cancer. In addition, we will determine whether the combination of breast MRI and mammography identifies smaller, earlier-stage tumors, which would lead to improved cure rates. We will also take the opportunity to determine the incidence and stage of breast cancer in this high-risk cohort.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2009
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 18, 2009
CompletedFirst Posted
Study publicly available on registry
June 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedNovember 8, 2011
November 1, 2011
2.3 years
June 18, 2009
November 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of breast cancer detected with addition of breast MRI
Once a year
Study Arms (1)
Breast MRI Screening
Interventions
Magnetic resonance imaging (MRI) scans of the breasts once per year
Breast x-ray used to detect breast cancer and look for abnormalities in the breast.
Eligibility Criteria
Women, breast cancer patients diagnosed with Hodgkin's lymphoma prior to 1995, who underwent mantle-field irradiation between 1970-1995 at M. D. Anderson Cancer Center.
You may qualify if:
- Female patients diagnosed with lymphoma prior to 1995
- The radiation therapy must have been delivered at M.D. Anderson from start to finish with complete records of dose received
- Patients must have received radiation therapy to the chest between the ages of 10 and 30
You may not qualify if:
- Patients with claustrophobia
- Obese patients (the equipment weight limit is 350 pounds and the maximum scanner bore diameter is 55 cm)
- Patients with myocardial infarction within 6 months of study entry
- Patients with unstable angina pectoris, uncontrolled congestive heart failure, or uncontrolled arrhythmias
- Patients with aneurysm clips, pacemakers, or other implanted devices that are not MRI compatible
- Pregnant patients
- Patients with compromised renal function, with a calculated glomerular filtration rate (cGFR) less than 60 ml/min/1.73m2.
- Patients who began their treatment outside of MD Anderson Cancer Center.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bouthaina Dabaja, MD
UT MD Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2009
First Posted
June 22, 2009
Study Start
June 1, 2009
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
November 8, 2011
Record last verified: 2011-11