Clinical Trials Directory

Trials / Completed

CompletedNCT03226925

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

Added Value of Mechanically-assisted Ventilation in the Treatment of Moving Tumours (Thoracic/Upper Abdomen) With Photon and Proton Therapies.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
23 (actual)
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTNon-invasive mechanically-assisted ventilationMechanically ventilation will be done through facial masks connected to a respirator. Volunteers/patients are fully conscious during the ventilation.
DIAGNOSTIC_TESTDynamic MRI acquisitionDynamic MRI acquisition are specific dynamic sequences intended to visualise the motion of internal structures (anatomical structures or tumour) under non-invasive mechanically-assisted ventilation
DIAGNOSTIC_TESTPlanning 4D-CTIn order to perform in-silico planning, 4D-CT will be acquired on patients under non-invasive mechanically-assisted ventilation

Timeline

Start date
2017-06-30
Primary completion
2019-06-01
Completion
2019-06-01
First posted
2017-07-24
Last updated
2019-07-15

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT03226925. Inclusion in this directory is not an endorsement.