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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04896242
• Other study ID #: 11190071
• Status: Completed
• Start date: January 9, 2020
• Est. completion date: April 1, 2024

Study information

• Verified date: April 2024
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: April 1, 2024
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Chile	Pontificia Universidad Catolica de Chile	Santiago	Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	High-sensitivity Cardiac Troponin-T	Troponin rises >99%th percentile of the upper reference limit	Baseline, 1 and 12 weeks after treatment
Other	N-Terminal pro-Brain Natriuretic Peptide	N-Terminal pro-Brain Natriuretic Peptide, rises >99%th percentile of the upper reference limit	Baseline, 1 and 12 weeks after treatment
Other	Circulating Endothelial Cells	Number of Circulating Endothelial Cells	Baseline, 1 and 12 weeks after treatment
Primary	Global Longitudinal Strain (Left Ventricle)	>5 Absolute drop or 12% Relative reduction from baseline	Baseline, 1 and 12 weeks after Treatment
Secondary	Cardiac Magnetic Resonance Cinema Imaging	Cinema imaging: Long axis balance, Balance 4 cameras, Short shaft full balance, Right ventricular balance	Baseline, 1 and 12 weeks after treatment
Secondary	Cardiac Magnetic Resonance Anatomical Image	Inversion recovery single shot balance 3D short axis covering the entire heart and aorta with free respiratory trigger	Baseline, 1 and 12 weeks after treatment
Secondary	Cardiac Magnetic Resonance Flow Image	2D outflow tract of the aorta 2D pulmonary artery outflow tract	Baseline, 1 and 12 weeks after treatment
Secondary	Cardiac Magnetic Resonance Quantitative Image	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	Baseline, 1 and 12 weeks after treatment