Skip to main content
Clinical Trials/NCT03226925
NCT03226925
Completed
N/A

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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain1 site in 1 country23 target enrollmentJune 30, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Thoracic Neoplasm
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Enrollment
23
Locations
1
Primary Endpoint
Measure in millimeters of the internal motion during non-invasive mechanically assisted ventilation, based on MRI images
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 30, 2017
End Date
June 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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 Outcomes

  • Dosimetric comparison(within 12 months)
  • Tolerance assessment(within 12 months)
  • Internal motion reproducibility with non-invasive mechanically assisted ventilation.(Within 12 months)

Study Sites (1)

Loading locations...

Similar Trials