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Trial record 72 of 1444 for:    Prediction | Recruiting, Not yet recruiting, Available Studies

Echocardiography for RILI Prediction

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ClinicalTrials.gov Identifier: NCT02501707
Recruitment Status : Recruiting
First Posted : July 17, 2015
Last Update Posted : June 8, 2018
Sponsor:
Collaborator:
Academisch Ziekenhuis Maastricht
Information provided by (Responsible Party):
Maastricht Radiation Oncology

Brief Summary:
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.

Condition or disease
NSCLC

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 : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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.
Actual Study Start Date : April 25, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Dyspnea score at three months after (chemo)radiotherapy, assessed by the patient version of the CTCv4.0 [ Time Frame: up to 3 months ]

Secondary Outcome Measures :
  1. Dyspnea score at six months after (chemo)radiotherapy, assessed by the patient version of CTCv4.0 [ Time Frame: up to 6 months ]
  2. Changes in dyspnea score after radiotherapy, compared to baseline [ Time Frame: up to 12 months ]
  3. Change in Left Ventricle Ejection Fraction (LVEF) (baseline versus 3-month after chemo radiation) [ Time Frame: up to 3 months ]
  4. Change in left atrial volume (2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation) [ Time Frame: up to 3 months ]
  5. 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 ]
  6. 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 ]
  7. Prevalence-based dyspnea measure, reflecting severity as well as duration of dyspnea [ Time Frame: up to 12 months ]
  8. Changes in physical activity levels and sedentary behavior, assessed by accelerometry [ Time Frame: up to 12 months ]
  9. Pulmonary function based on spirometry [ Time Frame: up to 3 months ]
  10. 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 ]
  11. Change in mitral inflow (2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation) [ Time Frame: up to 3 months ]
  12. Change in pulmonary vein inflow patterns (2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation) [ Time Frame: up to 3 months ]
  13. 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 ]
  14. 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 ]
  15. Haemoglobin parameters in the blood at baseline and during treatment [ Time Frame: up to 3 months ]
  16. Inflammatory parameters (CRP, IL-6 and TNFa) in the blood at baseline and during treatment [ Time Frame: up to 3 months ]
  17. 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 ]

Other Outcome Measures:
  1. Cardiac Comorbidity according to ICD v10 [ Time Frame: up to 12 months ]
  2. Radiomics (the evolving field of texture analysis) of normal tissue(heart and lung) [ Time Frame: up to 3 months ]
  3. Mitochondrial DNA (prognostic value of mtDNA for development of RILI) [ Time Frame: up to 12 months ]
  4. 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 ]
  5. Muscle strength, measured by respiratory mouth pressure measurement, maximum inspiratoire mouthpressure, (Pimax) [ Time Frame: up to 12 months ]
  6. 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 ]
  7. 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 ]

Biospecimen Retention:   Samples With DNA

Bloodsamples and saliva samples will be collected according to the biobank protocol at Maastro clinic to explore the prognostic value of mitochondrial DNA for development of radiation-induced lung injury.

Cardiac bloodmarkers: B-type Natriuretic Peptide (BNP), cardiac Troponin I and T will be measured.

Haemoglobin and inflammatory parameters (CRP, IL-6 and TNFa)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501707


Contacts
Contact: Cary Oberije, PhD +31 884455666 cary.oberije@maastro.nl
Contact: Sylvie Canisius +31 884455638 sylvie.canisius@maastro.nl

Locations
Netherlands
MAASTRO clinic Recruiting
Maastricht, Limburg, Netherlands, 6229 ET
Contact: Cary Oberij, PhD    +31 88 44 55 666    cary.oberije@maastro.nl   
Contact: Sylvie Canisius    +31 88 44 55 666    sylvie.canisius@maastro.nl   
Principal Investigator: Cary Oberije, PhD         
Maastricht University Medical Center Recruiting
Maastricht, Limburg, Netherlands, 6229 HX
Contact: Bas Kietselaer, MD,PhD       b.kietselaer@mumc.nl   
Principal Investigator: Bas Kietselaer, MD,PhD         
Principal Investigator: Anne-Marie Dingemans, MD,PhD         
Sponsors and Collaborators
Maastricht Radiation Oncology
Academisch Ziekenhuis Maastricht
Investigators
Principal Investigator: Cary Oberije, 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)

Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT02501707     History of Changes
Other Study ID Numbers: echocardiographyRILI
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018

Keywords provided by Maastricht Radiation Oncology:
echocardiography
radiation-induced lung injury
prognostic
chemo radiotherapy
non-small cell lung cancer
NSCLC