Multimodal Assesment of Acute Cardiac Toxicity Induced by Thoracic Radiotherapy in Cancer Patients

Pontificia Universidad Catolica de Chile1 site in 1 country47 target enrollmentJanuary 9, 2020

ConditionsRadiotherapy; Complications Cardiotoxicity Cancer Lung Cancer Breast Cancer Esophageal Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Radiotherapy; Complications
Sponsor: Pontificia Universidad Catolica de Chile
Enrollment: 47
Locations: 1
Primary Endpoint: Global Longitudinal Strain (Left Ventricle)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate and compare the changes by two modalities: Imaging by Strain by Speckle Tracking and Magnetic Resonance versus soluble markers of cardiac dysfunction as early predictors of cardio-toxicity in cancer patients receiving low or high doses of radiotherapy.

Registry

clinicaltrials.gov

Start Date

January 9, 2020

End Date

April 1, 2024

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Pontificia Universidad Catolica de Chile

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•≥18 year-old patients
•With histologically confirmed thoracic cancer (breast, esophagus or lung)
•Recommendation of thoracic radiotherapy (RT) with curative intent
•With or without chemotherapy
•All patients must be able to read and understand Spanish
•All patients must sign informed consent form.

Exclusion Criteria

•Patients with no medical records,
•Previously diagnosed with severe left ventricular dysfunction or a cardiac insufficiency
•Patients with metastatic disease and indication of palliative RT
•Patients with significant comorbidities associated to a \<5 year life expectancy.
•Patients previously treated with thoracic RT

Outcomes

Primary Outcomes

Global Longitudinal Strain (Left Ventricle)

Time Frame: Baseline, 1 and 12 weeks after Treatment

\>5 Absolute drop or 12% Relative reduction from baseline

Secondary Outcomes

Cardiac Magnetic Resonance Anatomical Image(Baseline, 1 and 12 weeks after treatment)
Cardiac Magnetic Resonance Quantitative Image(Baseline, 1 and 12 weeks after treatment)
Cardiac Magnetic Resonance Cinema Imaging(Baseline, 1 and 12 weeks after treatment)
Cardiac Magnetic Resonance Flow Image(Baseline, 1 and 12 weeks after treatment)