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
| Type | Name | Description |
|---|---|---|
| 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 |
| 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 |
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.