NCT02348684

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: Female
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Identification of "safe" dose volume constraints (DVC) for the heart from breast cancer radiotherapy would permit maximal oncologic benefit from radiation, identifying which patients require more complicated and resource consumptive radiation methods such as respiratory-gating or intensity modulated radiotherapy (IMRT) and establish patients who need targeted follow-up for their long term cardiac risk. Two recent technical developments now make it conceivable to identify the dose-volume relationship between heart dose and subsequent cardiac event risk: 1. CT based three dimensional conformal radiation delivery methods (3DCRT) where the precise radiation dose to any given heart volume is known, and 2. Cardiac MRI (CMR) that is more sensitive to prior methods of cardiac evaluation (e.g. SPECT) for detecting and measuring cardiac injury. An MRI, subject health questionnaire, clinical and dosimetric data will be included in the analysis.

Conditions

• Node Positive Breast Cancer

Interventions

Type	Name	Description
RADIATION	Radiation therapy groups	Radiation Therapy treatment between 2000 and 2007.

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-11-01
• Completion: 2014-12-01
• First posted: 2015-01-28
• Last updated: 2026-04-01
• Results posted: 2019-07-01

Locations

1 site across 1 country: United States