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Mechanically-assisted Ventilation in the Treatment of Moving Tumours With Photon and Proton Therapies

This study is currently recruiting participants.
Verified June 2017 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor:
ClinicalTrials.gov Identifier:
NCT03226925
First Posted: July 24, 2017
Last Update Posted: July 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  Purpose
Mechanical ventilation can be used to impose a completely regular pattern of breathing frequency and inflation volume on the patient for as long as required. This would considerably improve the reproducibility of the internal motion parameters, and thus facilitate the implementation of respiratory-synchronized techniques such as gating, tracking and four-digital optimization.

Condition Intervention
Thoracic Neoplasm Liver Cancer Ventilator Lung Radiotherapy; Complications Diagnostic Test: Non-invasive mechanically-assisted ventilation Diagnostic Test: Dynamic MRI acquisition Diagnostic Test: Planning 4D-CT

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
One group of patients with healthy volunteers and two groups with lung/upper abdomen cancer patients
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Added Value of Mechanically-assisted Ventilation in the Treatment of Moving Tumours (Thoracic/Upper Abdomen) With Photon and Proton Therapies.

Resource links provided by NLM:


Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • Measure in millimeters of the internal motion during non-invasive mechanically assisted ventilation, based on MRI images [ Time Frame: within 12 months ]
    This analysis will be based on dynamic MRI analysis made with healthy volunteers and also patients on non-invasive mechanically assisted ventilation. A well defined anatomical structure will be selected for the healthy volunteers while the tumor will be tracked in patients.


Secondary Outcome Measures:
  • Tolerance assessment [ Time Frame: within 12 months ]
    During all these acquisitions, the tolerance to the non-invasive mechanically assisted ventilation will be assessed by all the participants through a 5-steps scale.

  • Internal motion reproducibility with non-invasive mechanically assisted ventilation. [ Time Frame: Within 12 months ]
    This analysis will be done by comparing the motion of the internal structures/tumors at two different time points (MRI acquisition at two different time points). All these acquisitions will obviously be done in the same conditions on non-invasive mechanically assisted ventilation. Motion reproducibility will be analysed by comparing the baseline positions of anatomical structures/tumors on MRI images and the measures in millimeters of motion of the same anatomical structures/tumors.

  • Dosimetric comparison [ Time Frame: within 12 months ]
    This dosimetric comparison will be done in order to assess the impact of non-invasive mechanically-assisted ventilation on dose planning and delivery. Difference in dose (in Gy) to organ at risks will specially be compared through the DVH (dose-volume histogram) analysis.


Estimated Enrollment: 30
Actual Study Start Date: June 30, 2017
Estimated Study Completion Date: April 30, 2018
Estimated Primary Completion Date: April 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healthy volunteers on ventilation
Dynamic MRI acquisition will be performed at two different time points with 10 healthy volunteers under non-invasive mechanically-assisted ventilation with a respirator. Different modes will be compared (spontaneous, physiologic, shallow, slow and jet ventilation).
Diagnostic Test: Non-invasive mechanically-assisted ventilation
Mechanically ventilation will be done through facial masks connected to a respirator. Volunteers/patients are fully conscious during the ventilation.
Diagnostic Test: Dynamic MRI acquisition
Dynamic MRI acquisition are specific dynamic sequences intended to visualise the motion of internal structures (anatomical structures or tumour) under non-invasive mechanically-assisted ventilation
Experimental: Cancer patients on ventilation
Dynamic MRI acquisition will be performed at two different time points with 10 patients (intended for a radiation treatment of their thoracic or upper abdominal tumours) under non-invasive mechanically-assisted ventilation with a respirator. Different modes will be compared (spontaneous, physiologic, shallow, slow and jet ventilation).
Diagnostic Test: Non-invasive mechanically-assisted ventilation
Mechanically ventilation will be done through facial masks connected to a respirator. Volunteers/patients are fully conscious during the ventilation.
Diagnostic Test: Dynamic MRI acquisition
Dynamic MRI acquisition are specific dynamic sequences intended to visualise the motion of internal structures (anatomical structures or tumour) under non-invasive mechanically-assisted ventilation
Experimental: Planning with patients on ventilation
Planning 4D-CT will be performed with 10 patients (intended for a radiation treatment of their thoracic or upper abdominal tumours) under non-invasive mechanically-assisted ventilation with a respirator. Different ventilation modes will be compared (spontaneous, physiologic, shallow, slow and jet ventilation).
Diagnostic Test: Non-invasive mechanically-assisted ventilation
Mechanically ventilation will be done through facial masks connected to a respirator. Volunteers/patients are fully conscious during the ventilation.
Diagnostic Test: Planning 4D-CT
In order to perform in-silico planning, 4D-CT will be acquired on patients under non-invasive mechanically-assisted ventilation

Detailed Description:

This will be a three-phase analysis :

First, different ventilation modes will be tested and compared on healthy volunteers. This phase will be analysed with a ventilator and with dynamic MRI in order to measure the movement of anatomical structures in each ventilation mode (intra-fraction analysis). Further, we will repeat these exams in order to compare them with the first ones, in order to analyse the reproducibility and baseline shifts (inter-fraction analysis).

Here are the different ventilation modes

  • spontaneous breathing
  • physiologic ventilation mode :
  • shallow ventilation mode
  • slow ventilation mode
  • Jet Ventilation mode

Second phase will be done with patients that are intended to have a radiation treatment for thoracic or upper abdominal tumors. All the previous ventilation modes will be analysed during repeated MRI, again in order to perform intra- and inter-fraction analysis of the tumor motion.

Third phase also concerned patients intended to have a radiation treatment. It will be an in-silico-planning analysis in order to quantify dosimetric outcomes of these ventilation modes.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • No comorbidity for healthy volunteers
  • Cancer patients with either lung or upper abdomen (liver/pancreas) tumours treated with radiation therapy.

Exclusion Criteria:

  • severe lung disease or emphysema
  • previous history of pneumothorax
  • claustrophobia
  Contacts and Locations
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): NCT03226925


Contacts
Contact: Xavier Geets, MD, PhD 0032 2 764 ext 4719 xavier.geets@uclouvain.be
Contact: Geneviève Van Ooteghem, MD 0032 2 764 ext 9537 genevieve.vanooteghem@uclouvain.be

Locations
Belgium
Cliniques Universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Xavier Geets, MD, PhD    0032 2 764 ext 4719    xavier.geets@uclouvain.be   
Contact: Geneviève Van Ooteghem, MD    0032 2 764 ext 5107    genevieve.vanooteghem@uclouvain.be   
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Principal Investigator: Xavier Geets, MD, PhD Cliniques universitaires Saint-Luc
  More Information

Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03226925     History of Changes
Other Study ID Numbers: 2017/23MAI/294
First Submitted: June 27, 2017
First Posted: July 24, 2017
Last Update Posted: July 24, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Not decided at this moment

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
thoracic tumors
motion management
radiotherapy
ventilator

Additional relevant MeSH terms:
Liver Neoplasms
Thoracic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases