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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-30

Study Completion Date

2019-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Influence of Non-invasive Ventilation on Metabolism in Healthy Volunteers

NCT04178694

Energy Expenditure Non-invasive Ventilation Metabolism

COMPLETED NA

Non-invasive Ventilation and Physical Activity

NCT02951572

Neuromuscular Diseases

TERMINATED NA

Effect of Ventilation Mode on Lung Deposition of a Radiolabeled Aerosol During Mechanical Ventilation: Barometric Versus Volumetric

NCT01879488

Post-operative Neurosurgery

COMPLETED NA

Effect of Variable Volume Ventilation on Lung Compliance

NCT03661502

Lung Injury

UNKNOWN NA

Non-invasive Ventilation in Terminally Ill Cancer Patients

NCT00533143

Cancer

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Thoracic Neoplasm Liver Cancer Ventilator Lung Radiotherapy; Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

One group of patients with healthy volunteers and two groups with lung/upper abdomen cancer patients

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy volunteers on ventilation

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).

Group Type EXPERIMENTAL