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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

• Study Contact: Name: Tomas M Merino, MD; Phone Number: 6832 +5622352000; Email: tmerino@med.puc.cl

Study Locations

• Chile
  • Metropolitana
    • Santiago, Metropolitana, Chile
      • Pontificia Universidad Catolica de Chile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with cancer of the thoracic area (lung, breast, esophagus or other thoracic locations) that will receive curative radiotherapy to the thoracic region at Pontificia Universidad Católica de Chile.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Longitudinal Strain (Left Ventricle)	>5 Absolute drop or 12% Relative reduction from baseline	Baseline, 1 and 12 weeks after Treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac Magnetic Resonance Cinema Imaging	Cinema imaging: Long axis balance, Balance 4 cameras, Short shaft full balance, Right ventricular balance	Baseline, 1 and 12 weeks after treatment
Cardiac Magnetic Resonance Anatomical Image	Inversion recovery single shot balance 3D short axis covering the entire heart and aorta with free respiratory trigger	Baseline, 1 and 12 weeks after treatment
Cardiac Magnetic Resonance Flow Image	2D outflow tract of the aorta 2D pulmonary artery outflow tract	Baseline, 1 and 12 weeks after treatment
Cardiac Magnetic Resonance Quantitative Image	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	Baseline, 1 and 12 weeks after treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
High-sensitivity Cardiac Troponin-T	Troponin rises >99%th percentile of the upper reference limit	Baseline, 1 and 12 weeks after treatment
N-Terminal pro-Brain Natriuretic Peptide	N-Terminal pro-Brain Natriuretic Peptide, rises >99%th percentile of the upper reference limit	Baseline, 1 and 12 weeks after treatment
Circulating Endothelial Cells	Number of Circulating Endothelial Cells	Baseline, 1 and 12 weeks after treatment

Collaborators and Investigators

• Sponsor: Pontificia Universidad Catolica de Chile
• Investigators: Principal Investigator: Tomas Merino Lara, Pontificia Universidad Catolica de Chile

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2020
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: May 9, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Wounds and Injuries; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Cardiotoxicity
• Other Study ID Numbers: 11190071

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No