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Completed

NCT Number: NCT04896242

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.

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Key information

Conditions

Radiotherapy; Complications Breast Cancer Breast Diseases Breast Neoplasms Cancer Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Digestive System Diseases Digestive System Neoplasms Drug-Related Side Effects and Adverse Reactions Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Heart Diseases Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Cardiac Magnetic Resonance Cinema Imaging

    Time frame: Baseline, 1 and 12 weeks after treatment

    Cinema imaging: Long axis balance, Balance 4 cameras, Short shaft full balance, Right ventricular balance

  2. Cardiac Magnetic Resonance Anatomical Image

    Time frame: 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

  3. Cardiac Magnetic Resonance Flow Image

    Time frame: Baseline, 1 and 12 weeks after treatment

    2D outflow tract of the aorta 2D pulmonary artery outflow tract

  4. Cardiac Magnetic Resonance Quantitative Image

    Time frame: 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

Other outcomes

  1. High-sensitivity Cardiac Troponin-T

    Time frame: Baseline, 1 and 12 weeks after treatment

    Troponin rises >99%th percentile of the upper reference limit

  2. N-Terminal pro-Brain Natriuretic Peptide

    Time frame: Baseline, 1 and 12 weeks after treatment

    N-Terminal pro-Brain Natriuretic Peptide, rises >99%th percentile of the upper reference limit

  3. Circulating Endothelial Cells

    Time frame: Baseline, 1 and 12 weeks after treatment

    Number of Circulating Endothelial Cells

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2024
First posted
May 21, 2021
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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