Echocardiography for RILI Prediction

December 2, 2019 updated by: Maastricht Radiation Oncology

The Value of Echocardiography for Prediction of Radiation-induced Lung Injury in Non-small Cell Lung Cancer Patients Treated With Chemoradiation: an Onco-cardiac Prospective Cohort Study.

Severe radiation-induced lung injury (RILI) occurs in approximately 20% of the lung cancer patients, who are treated with curative chemoradiation. In this study the investigators want to evaluate the prognostic value of baseline cardiac function assessed with echocardiography for prediction of RILI.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Severe radiation-induced lung injury (RILI) occurs in approximately 20% of the lung cancer patients, who are treated with curative chemoradiation (CRT).This side-effect can heavily impact quality of life and is a dose-limiting factor for the treatment. Identifying high risk patients before the start of the treatment would make it possible to adapt the treatment by choosing another radiation technique or proton therapy. However, despite the fact that many patient and treatment characteristics have been associated with RILI, it is not possible to accurately predict the risk of RILI for individual patients. Recently, it has been shown that the radiation dose to the heart is a risk factor for lung toxicity in both animal and clinical studies. Also, in a study, carried out jointly by CARIM and GROW, it was found that patients with a previous diagnosis of cardiac disease had a significantly higher risk to develop RILI after CRT (p-value <0.001), even with low or no radiation dose to the heart. It is unknown whether asymptomatic cardiac comorbidity is also related to development of RILI. Taking into account that approximately 30% of all lung cancer patients suffer from symptomatic cardiac comorbidity at the start of cancer treatment, there is an urgent need for research projects focusing on cardio-oncology. These projects will make it possible to unravel the complex relationship between heart, lungs, chemotherapy and radiation treatment. In the current project the investigators hypothesize that biomarkers based on echocardiography, which reflects cardiac function, are prognostic for development of radiation induced lung injury after chemoradiotherapy. In addition, the investigators will validate our previous finding that presence of cardiac comorbidity is associated with RILI.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 ET
        • Maastro Clinic
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients referred to MAASTRO Clinic with non-small cell lung cancer stage I-III disease can be included in this study (approximately 160 patients per year).

Description

Inclusion Criteria:

  • Clinical stage I-III non small cell lung cancer, excluding malignant pleural/pericardial effusion
  • Planned for curatively intended primary (chemo)radiotherapy, due to irresectable disease and/or medical inoperability
  • WHO performance status 0-2
  • No history of prior chest radiotherapy
  • No uncontrolled infectious disease
  • No other active malignancy
  • No prior lung surgery (VATS, wedge resection, segment resection, lobectomy)
  • Willing and able to comply with the study prescriptions
  • 18 years or older
  • Ability to give and having given written informed consent before patient registration

Exclusion Criteria:

  • malignant pleural/pericardial effusion
  • history of prior chest radiotherapy
  • uncontrolled infectious disease
  • other active malignancy
  • prior lung surgery (VATS, wedge resection, segment resection, lobectomy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Dyspnea score at three months after (chemo)radiotherapy, assessed by the patient version of the CTCv4.0
Time Frame: up to 3 months
up to 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Dyspnea score at six months after (chemo)radiotherapy, assessed by the patient version of CTCv4.0
Time Frame: up to 6 months
up to 6 months
Changes in dyspnea score after radiotherapy, compared to baseline
Time Frame: up to 12 months
up to 12 months
Change in Left Ventricle Ejection Fraction (LVEF) (baseline versus 3-month after chemo radiation)
Time Frame: up to 3 months
up to 3 months
Change in left atrial volume (2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation)
Time Frame: up to 3 months
up to 3 months
Radiation pneumonitis at 3-months after start of radio(chemo)therapy, assessed on a follow-up 3D CT scan image.
Time Frame: up to 3 months
up to 3 months
Lung fibrosis score at 6-months after start of chemo radiation, assessed on a follow-up CT scan image
Time Frame: up to 6 months
up to 6 months
Prevalence-based dyspnea measure, reflecting severity as well as duration of dyspnea
Time Frame: up to 12 months
up to 12 months
Changes in physical activity levels and sedentary behavior, assessed by accelerometry
Time Frame: up to 12 months
up to 12 months
Pulmonary function based on spirometry
Time Frame: up to 3 months
up to 3 months
Change in left atrial ejection fraction (from pts in SR)(2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation)
Time Frame: up to 3 months
up to 3 months
Change in mitral inflow (2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation)
Time Frame: up to 3 months
up to 3 months
Change in pulmonary vein inflow patterns (2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation)
Time Frame: up to 3 months
up to 3 months
Change in tissue doppler patterns of the mitral annulus (2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation)
Time Frame: up to 3 months
up to 3 months
Cardiac blood biomarkers at baseline and during treatment, Brain natriuretic peptide(BNP), troponin I (TnI) and troponin T(TnT)
Time Frame: up to 3 months
up to 3 months
Haemoglobin parameters in the blood at baseline and during treatment
Time Frame: up to 3 months
up to 3 months
Inflammatory parameters (CRP, IL-6 and TNFa) in the blood at baseline and during treatment
Time Frame: up to 3 months
up to 3 months
Time trends in physical activity and sedentary time from baseline till 12 months after radiotherapy, measured by accelerometers in four weekly periods
Time Frame: up to 12 months
up to 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Cardiac Comorbidity according to ICD v10
Time Frame: up to 12 months
up to 12 months
Radiomics (the evolving field of texture analysis) of normal tissue(heart and lung)
Time Frame: up to 3 months
up to 3 months
Mitochondrial DNA (prognostic value of mtDNA for development of RILI)
Time Frame: up to 12 months
up to 12 months
Body composition, analysed by evaluation of muscle mass and fat mass on computed tomography (CT) scans at a standardized vertebral landmark (third lumbar vertebra)
Time Frame: up to 12 months
up to 12 months
Muscle strength, measured by respiratory mouth pressure measurement, maximum inspiratoire mouthpressure, (Pimax)
Time Frame: up to 12 months
up to 12 months
arterial inflammation as revealed by 18F-FDG PET . Standardized quantification parameters will be applied: Standardized uptake value (SUV), target-to-background ratio (TBR), most diseased segment analysis
Time Frame: up to 12 months
up to 12 months
Calcification score of the coronary artery and thoracic aorta. The calcification will be quantified by using fully automated scoring and graded according to the Agatston score method
Time Frame: up to 3 months
up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maastricht Radiation Oncology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Academisch Ziekenhuis Maastricht

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dirk De Ruysscher, PhD., MAASTRO-clinic (senior researcher)
  • Principal Investigator: Bas Kietselaer, MD,Phd, AzM/MUMC (cardiologist)
  • Principal Investigator: Judith van Loon, MD,PhD, MAASTRO-clinic (radiation oncologist)
  • Principal Investigator: Philippe Lambin, Prof,MD,Phd, MAASTRO-clinic (radiation oncologist)
  • Principal Investigator: Anne-Marie Dingemans, MD, PhD, MAASTRO-clinic (pulmonogist)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 12, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 12, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • echocardiographyRILI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings