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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04896242
Enrollment
47
Registered
2021-05-21
Start date
2020-01-09
Completion date
2024-04-01
Last updated
2024-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Cancer, Cardiotoxicity, Esophageal Cancer, Lung Cancer, Radiotherapy; Complications

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.

Interventions

None listed

Sponsors

Pontificia Universidad Catolica de Chile
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Global Longitudinal Strain (Left Ventricle)Baseline, 1 and 12 weeks after Treatment\>5 Absolute drop or 12% Relative reduction from baseline

Secondary

MeasureTime frameDescription
Cardiac Magnetic Resonance Anatomical ImageBaseline, 1 and 12 weeks after treatmentInversion recovery single shot balance 3D short axis covering the entire heart and aorta with free respiratory trigger
Cardiac Magnetic Resonance Cinema ImagingBaseline, 1 and 12 weeks after treatmentCinema imaging: Long axis balance, Balance 4 cameras, Short shaft full balance, Right ventricular balance
Cardiac Magnetic Resonance Flow ImageBaseline, 1 and 12 weeks after treatment2D outflow tract of the aorta 2D pulmonary artery outflow tract
Cardiac Magnetic Resonance Quantitative ImageBaseline, 1 and 12 weeks after treatmentT1 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

MeasureTime frameDescription
Circulating Endothelial CellsBaseline, 1 and 12 weeks after treatmentNumber of Circulating Endothelial Cells
N-Terminal pro-Brain Natriuretic PeptideBaseline, 1 and 12 weeks after treatmentN-Terminal pro-Brain Natriuretic Peptide, rises \>99%th percentile of the upper reference limit
High-sensitivity Cardiac Troponin-TBaseline, 1 and 12 weeks after treatmentTroponin rises \>99%th percentile of the upper reference limit

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026