Evaluate Cardiac Function Using Cardiac MRI and Dosimetric Correlation
Pilot Study to Evaluate Cardiac Function Using Cardiac MRI and Dosimetric Correlation in Women Treated for Node Positive Breast Cancer With Three- Dimensional Conformal Radiation Therapy (3DCRT)
1 other identifier
observational
20
1 country
1
Brief Summary
The association between radiation exposure and cardiac disease is well recognized, it is not fully understood if there exists an optimal or "safe" radiation dose-volume relationship.
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 Mar 2012
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
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Posted
Study publicly available on registry
January 28, 2015
CompletedResults Posted
Study results publicly available
July 1, 2019
CompletedApril 1, 2026
March 1, 2026
2.7 years
August 22, 2014
August 23, 2018
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cardiac MRI Parameters
Cardiac MRI parameters include Left Ventricular (LV) ejection fraction, LV mass (indexed), LV dimensions, extracellular volume (ECV), and late gadolinium enhancement (LGE).
day of MRI scan
Secondary Outcomes (1)
Correlate Cardiac MRI Parameters
the day of MRI
Study Arms (1)
Radiation therapy groups
Risk groups based on dosimetric radiation parameters.
Interventions
Radiation Therapy treatment between 2000 and 2007.
Eligibility Criteria
Women Treated for Node Positive Breast Cancer with Three-Dimensional Conformal Radiation Therapy (3DCRT)
You may qualify if:
- Women with node positive breast cancer treated with surgery, anthracycline-based or similar cardiotoxic chemotherapy, and regional nodal irradiation between 2000-2007.
You may not qualify if:
- Women who have not received anthracycline-based or similar cardiotoxic chemotherapy, and regional nodal irradiation between 2000-2007.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Froedtert Hospital
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
Assomull RG, Prasad SK, Lyne J, Smith G, Burman ED, Khan M, Sheppard MN, Poole-Wilson PA, Pennell DJ. Cardiovascular magnetic resonance, fibrosis, and prognosis in dilated cardiomyopathy. J Am Coll Cardiol. 2006 Nov 21;48(10):1977-85. doi: 10.1016/j.jacc.2006.07.049. Epub 2006 Oct 31.
PMID: 17112987BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Carmen Bergom
- Organization
- Medical College of Wisconsin
Study Officials
- PRINCIPAL INVESTIGATOR
Carmen R Bergom, MD, PhD
Medical College of Wisconsin
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2014
First Posted
January 28, 2015
Study Start
March 1, 2012
Primary Completion
November 1, 2014
Study Completion
December 1, 2014
Last Updated
April 1, 2026
Results First Posted
July 1, 2019
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
Data available upon request after publication of findings.