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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

Tracking Information
First Submitted Date May 9, 2021
First Posted Date May 21, 2021
Last Update Posted Date May 21, 2021
Actual Study Start Date January 9, 2020
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 17, 2021)
Global Longitudinal Strain (Left Ventricle) [ Time Frame: Baseline, 1 and 12 weeks after Treatment ]
>5 Absolute drop or 12% Relative reduction from baseline
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 17, 2021)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 17, 2021)
  • High-sensitivity Cardiac Troponin-T [ Time Frame: Baseline, 1 and 12 weeks after treatment ]
    Troponin rises >99%th percentile of the upper reference limit
  • 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
  • Circulating Endothelial Cells [ Time Frame: Baseline, 1 and 12 weeks after treatment ]
    Number of Circulating Endothelial Cells
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Multimodal Assesment of Acute Cardiac Toxicity Induced by Thoracic Radiotherapy in Cancer Patients
Official Title Multimodal Assesment of Acute Cardiac Toxicity Induced by Thoracic Radiotherapy in Cancer Patients
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 Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Months
Biospecimen Not Provided
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.
Condition
  • Radiotherapy; Complications
  • Cardiotoxicity
  • Cancer
  • Lung Cancer
  • Breast Cancer
  • Esophageal Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 17, 2021)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 31, 2023
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Tomas M Merino, MD +5622352000 ext 6832 tmerino@med.puc.cl
Listed Location Countries Chile
Removed Location Countries  
 
Administrative Information
NCT Number NCT04896242
Other Study ID Numbers 11190071
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Pontificia Universidad Catolica de Chile
Study Sponsor Pontificia Universidad Catolica de Chile
Collaborators Not Provided
Investigators
Principal Investigator: Tomas Merino Lara Pontificia Universidad Catolica de Chile
PRS Account Pontificia Universidad Catolica de Chile
Verification Date May 2021