search
Back to results

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

Primary Purpose

Thoracic Neoplasm, Liver Cancer, Ventilator Lung

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Non-invasive mechanically-assisted ventilation
Dynamic MRI acquisition
Planning 4D-CT
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Thoracic Neoplasm focused on measuring thoracic tumors, motion management, radiotherapy, ventilator

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cliniques Universitaires Saint-Luc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Healthy volunteers on ventilation

Cancer patients on ventilation

Planning with patients on ventilation

Arm Description

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).

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).

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).

Outcomes

Primary Outcome Measures

Measure in millimeters of the internal motion during non-invasive mechanically assisted ventilation, based on MRI images
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
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.
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
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.

Full Information

First Posted
June 27, 2017
Last Updated
July 12, 2019
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
search

1. Study Identification

Unique Protocol Identification Number
NCT03226925
Brief Title
Mechanically-assisted Ventilation in the Treatment of Moving Tumours With Photon and Proton Therapies
Official Title
Added Value of Mechanically-assisted Ventilation in the Treatment of Moving Tumours (Thoracic/Upper Abdomen) With Photon and Proton Therapies.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 30, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Neoplasm, Liver Cancer, Ventilator Lung, Radiotherapy; Complications
Keywords
thoracic tumors, motion management, radiotherapy, ventilator

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One group of patients with healthy volunteers and two groups with lung/upper abdomen cancer patients
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy volunteers on ventilation
Arm Type
Experimental
Arm Description
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).
Arm Title
Cancer patients on ventilation
Arm Type
Experimental
Arm Description
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).
Arm Title
Planning with patients on ventilation
Arm Type
Experimental
Arm Description
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).
Intervention Type
Diagnostic Test
Intervention Name(s)
Non-invasive mechanically-assisted ventilation
Intervention Description
Mechanically ventilation will be done through facial masks connected to a respirator. Volunteers/patients are fully conscious during the ventilation.
Intervention Type
Diagnostic Test
Intervention Name(s)
Dynamic MRI acquisition
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Planning 4D-CT
Intervention Description
In order to perform in-silico planning, 4D-CT will be acquired on patients under non-invasive mechanically-assisted ventilation
Primary Outcome Measure Information:
Title
Measure in millimeters of the internal motion during non-invasive mechanically assisted ventilation, based on MRI images
Description
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.
Time Frame
within 12 months
Secondary Outcome Measure Information:
Title
Tolerance assessment
Description
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.
Time Frame
within 12 months
Title
Internal motion reproducibility with non-invasive mechanically assisted ventilation.
Description
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.
Time Frame
Within 12 months
Title
Dosimetric comparison
Description
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.
Time Frame
within 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Geets, MD, PhD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Not decided at this moment

Learn more about this trial

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

We'll reach out to this number within 24 hrs