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

Completed

• Conditions: Radiotherapy; Complications; Lung Cancer; Esophageal Cancer; Cancer; Cardiotoxicity; Breast Cancer

• Registration Number: NCT04896242
• Lead Sponsor: Pontificia Universidad Catolica de Chile

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-09
• Study First Submitted: 2021-05-09
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-21
• Primary Completion: 2022-10-31
• Status Verified: 2024-04
• Study Completion: 2024-04-01
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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,
• Pregnant
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global Longitudinal Strain (Left Ventricle)	Baseline, 1 and 12 weeks after Treatment	\>5 Absolute drop or 12% Relative reduction from baseline

Secondary Outcome Measures

Name	Time	Method
Cardiac Magnetic Resonance Anatomical Image	Baseline, 1 and 12 weeks after treatment	Inversion recovery single shot balance 3D short axis covering the entire heart and aorta with free respiratory trigger
Cardiac Magnetic Resonance Quantitative Image	Baseline, 1 and 12 weeks after treatment	T1 map short axis apical section T1 map short axis medial section T1 map short axis basal section; T2 map short axis apical section T2 map short axis medial section T2 map short axis basal section
Cardiac Magnetic Resonance Cinema Imaging	Baseline, 1 and 12 weeks after treatment	Cinema imaging: Long axis balance, Balance 4 cameras, Short shaft full balance, Right ventricular balance
Cardiac Magnetic Resonance Flow Image	Baseline, 1 and 12 weeks after treatment	2D outflow tract of the aorta 2D pulmonary artery outflow tract

Trial Locations

Locations (1)

Pontificia Universidad Catolica de Chile; 🇨🇱 Santiago, Metropolitana, Chile