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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Completed

Conditions: Thoracic Neoplasm; Radiotherapy; Complications; Ventilator Lung; Liver Cancer

Treatments: Diagnostic Test: Non-invasive mechanically-assisted ventilation; Diagnostic Test: Planning 4D-CT; Diagnostic Test: Dynamic MRI acquisition

Study type: Interventional

Funder types: Other

Identifiers

NCT03226925

2017/23MAI/294

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 3 patient groups

Healthy volunteers on ventilation

Experimental group

Description:

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).

Treatment:

Diagnostic Test: Non-invasive mechanically-assisted ventilation

Diagnostic Test: Dynamic MRI acquisition

Cancer patients on ventilation

Experimental group

Description:

Dynamic MRI acquisition will be performed at two different time points with 10 patients (intended for a radiation treatment of their thoracic or upper abdominal tumours) under non-invasive mechanically-assisted ventilation with a respirator. Different modes will be compared (spontaneous, physiologic, shallow, slow and jet ventilation).

Treatment:

Diagnostic Test: Non-invasive mechanically-assisted ventilation

Diagnostic Test: Dynamic MRI acquisition

Planning with patients on ventilation

Experimental group

Description:

Planning 4D-CT will be performed with 10 patients (intended for a radiation treatment of their thoracic or upper abdominal tumours) under non-invasive mechanically-assisted ventilation with a respirator. Different ventilation modes will be compared (spontaneous, physiologic, shallow, slow and jet ventilation).

Treatment:

Diagnostic Test: Non-invasive mechanically-assisted ventilation

Diagnostic Test: Planning 4D-CT