Radiotherapy; ComplicationsNCT04896242
Multimodal Assesment of Acute Cardiac Toxicity Induced by Thoracic Radiotherapy in Cancer Patients
An observational study of Radiotherapy; Complications and Cardiotoxicity, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiotherapy; Complications, Cardiotoxicity, Cancer
- How many people
- 47 participants
- Where
- 1 siteChile
- Study dates
- 9 Jan 2020to 1 Apr 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Chile1 site
Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan
About this study
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.
- Conditions
- Radiotherapy; Complications, Cardiotoxicity, Cancer, Lung Cancer, Breast Cancer, Esophageal Cancer
- Medical subject headings
- Cardiotoxicity, Neoplasms, Lung Neoplasms, Breast Neoplasms, Esophageal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Longitudinal Strain (Left Ventricle)
>5 Absolute drop or 12% Relative reduction from baseline
Measured: Baseline, 1 and 12 weeks after Treatment
Secondary outcomes (4)
Cardiac Magnetic Resonance Cinema Imaging
Cinema imaging: Long axis balance, Balance 4 cameras, Short shaft full balance, Right ventricular balance
Measured: Baseline, 1 and 12 weeks after treatment
Cardiac Magnetic Resonance Anatomical Image
Inversion recovery single shot balance 3D short axis covering the entire heart and aorta with free respiratory trigger
Measured: Baseline, 1 and 12 weeks after treatment
Cardiac Magnetic Resonance Flow Image
2D outflow tract of the aorta 2D pulmonary artery outflow tract
Measured: Baseline, 1 and 12 weeks after treatment
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
Measured: Baseline, 1 and 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start9 Jan 2020
- Primary completion31 Oct 2022
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiotherapy; ComplicationsStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tomas Merino Lara, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896242
- Sponsor's protocol ID
- 11190071
- Status last verified
- Apr 2024
- First submitted
- 9 May 2021
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Assesment of Acute Cardiac Toxicity Induced by Thoracic Radiotherapy in Cancer Patients
- ClinicalTrials.gov ID
- NCT04896242
- Acronym / sponsor ID
- 11190071
- Conditions
- Radiotherapy; Complications, Cardiotoxicity, Cancer, Lung Cancer, Breast Cancer, Esophageal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- ≥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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Global Longitudinal Strain (Left Ventricle)
Time frame: Baseline, 1 and 12 weeks after Treatment
>5 Absolute drop or 12% Relative reduction from baseline
4 secondary outcomes
Cardiac Magnetic Resonance Cinema Imaging
Time frame: Baseline, 1 and 12 weeks after treatment
Cardiac Magnetic Resonance Anatomical Image
Time frame: Baseline, 1 and 12 weeks after treatment
Cardiac Magnetic Resonance Flow Image
Time frame: Baseline, 1 and 12 weeks after treatment
Cardiac Magnetic Resonance Quantitative Image
Time frame: Baseline, 1 and 12 weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomas Merino Lara principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiotherapy; Complications and Cardiotoxicity, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Longitudinal Strain (Left Ventricle) (time frame: Baseline, 1 and 12 weeks after Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.