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

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ClinicalTrials.gov Identifier: NCT04896242
Recruitment Status : Recruiting
First Posted : May 21, 2021
Last Update Posted : May 21, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Radiotherapy; Complications Cardiotoxicity Cancer Lung Cancer Breast Cancer Esophageal Cancer

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Multimodal Assesment of Acute Cardiac Toxicity Induced by Thoracic Radiotherapy in Cancer Patients
Actual Study Start Date : January 9, 2020
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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,
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04896242


Contacts
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Contact: Tomas M Merino, MD +5622352000 ext 6832 tmerino@med.puc.cl

Locations
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Chile
Pontificia Universidad Catolica de Chile Recruiting
Santiago, Metropolitana, Chile
Contact: Tomas Merino, MD    +5623542000 ext 6832      
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
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Principal Investigator: Tomas Merino Lara Pontificia Universidad Catolica de Chile
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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT04896242    
Other Study ID Numbers: 11190071
First Posted: May 21, 2021    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiotoxicity
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries