Clinical trial NCT03226925: 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
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Neoplasm
Liver Cancer
Ventilator Lung
Radiotherapy; Complications
Keywords: thoracic tumors
motion management
radiotherapy
ventilator
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group of patients with healthy volunteers and two groups with lung/upper abdomen cancer patients
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Measure in millimeters of the internal motion during non-invasive mechanically assisted ventilation, based on MRI images
timeFrame: within 12 months
Secondary outcomes:
measure: Tolerance assessment
timeFrame: within 12 months
measure: Internal motion reproducibility with non-invasive mechanically assisted ventilation.
timeFrame: Within 12 months
measure: Dosimetric comparison
timeFrame: within 12 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Xavier Geets, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: