Evaluate Cardiac Function Using Cardiac MRI and Dosimetric Correlation

Completed

• Conditions: Node Positive Breast Cancer
• Interventions: Radiation: Radiation therapy groups

• Registration Number: NCT02348684
• Lead Sponsor: Medical College of Wisconsin

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.

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2014-08-22
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Study First Submitted QC: 2015-01-22
• Study First Posted: 2015-01-28
• Results First Submitted: 2018-08-23
• Results First Submitted QC: 2019-04-03
• Results First Posted: 2019-07-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Women with node positive breast cancer treated with surgery, anthracycline-based or similar cardiotoxic chemotherapy, and regional nodal irradiation between 2000-2007.

Exclusion Criteria

• Women who have not received anthracycline-based or similar cardiotoxic chemotherapy, and regional nodal irradiation between 2000-2007.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Radiation therapy groups	Radiation therapy groups	Risk groups based on dosimetric radiation parameters.

Primary Outcome Measures

Name	Time	Method
Cardiac MRI Parameters	day of MRI scan	Cardiac MRI parameters include Left Ventricular (LV) ejection fraction, LV mass (indexed), LV dimensions, extracellular volume (ECV), and late gadolinium enhancement (LGE).

Secondary Outcome Measures

Name	Time	Method
Correlate Cardiac MRI Parameters	the day of MRI	Correlate cardiac MRI parameters with pre-treatment heart imaging and cardiac dose volume constraints as a measure of cardiac injury after partial heart irradiation in women with node positive breast cancer treated with surgery, anthracycline-based chemotherapy and regional nodal irradiation.

Trial Locations

Locations (1)

Froedtert Hospital; 🇺🇸 Milwaukee, Wisconsin, United States