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

Sponsor
Pontificia Universidad Catolica de Chile (Other)
Overall Status
Recruiting
CT.gov ID
NCT04896242
Collaborator
(none)
60
Enrollment
1
Location
45.7
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Multimodal Assesment of Acute Cardiac Toxicity Induced by Thoracic Radiotherapy in Cancer Patients
    Actual Study Start Date :
    Jan 9, 2020
    Anticipated Primary Completion Date :
    Oct 31, 2022
    Anticipated Study Completion Date :
    Oct 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Global Longitudinal Strain (Left Ventricle) [Baseline, 1 and 12 weeks after Treatment]

      >5 Absolute drop or 12% Relative reduction from baseline

    Secondary Outcome Measures

    1. 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

    2. 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

    3. Cardiac Magnetic Resonance Flow Image [Baseline, 1 and 12 weeks after treatment]

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

    4. 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

    Other Outcome Measures

    1. High-sensitivity Cardiac Troponin-T [Baseline, 1 and 12 weeks after treatment]

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

    2. N-Terminal pro-Brain Natriuretic Peptide [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 [Baseline, 1 and 12 weeks after treatment]

      Number of Circulating Endothelial Cells

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pontificia Universidad Catolica de Chile Santiago Metropolitana Chile

    Sponsors and Collaborators

    • Pontificia Universidad Catolica de Chile

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pontificia Universidad Catolica de Chile
    ClinicalTrials.gov Identifier:
    NCT04896242
    Other Study ID Numbers:
    • 11190071
    First Posted:
    May 21, 2021
    Last Update Posted:
    May 21, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cardiotoxicity

    Study Results

    No Results Posted as of May 21, 2021