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

NCT03226925 | Completed

• 1 other identifier: 2017/23MAI/294
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

thoracic tumors; motion management; radiotherapy; ventilator

Outcome Measures

Primary Outcomes (1)

• Measure in millimeters of the internal motion during non-invasive mechanically assisted ventilation, based on MRI images

  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.

  within 12 months

Secondary Outcomes (3)

• Tolerance assessment

  within 12 months

• Internal motion reproducibility with non-invasive mechanically assisted ventilation.

  Within 12 months

• Dosimetric comparison

  within 12 months

Study Arms (3)

Healthy volunteers on ventilation

EXPERIMENTAL

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).

Diagnostic Test: Non-invasive mechanically-assisted ventilation; Diagnostic Test: Dynamic MRI acquisition

Cancer patients on ventilation

EXPERIMENTAL

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).

Diagnostic Test: Non-invasive mechanically-assisted ventilation; Diagnostic Test: Dynamic MRI acquisition

Planning with patients on ventilation

EXPERIMENTAL

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).

Diagnostic Test: Non-invasive mechanically-assisted ventilation; Diagnostic Test: Planning 4D-CT

Interventions

Non-invasive mechanically-assisted ventilation DIAGNOSTIC_TEST

Mechanically ventilation will be done through facial masks connected to a respirator. Volunteers/patients are fully conscious during the ventilation.

Cancer patients on ventilation; Healthy volunteers on ventilation; Planning with patients on ventilation

Dynamic MRI acquisition DIAGNOSTIC_TEST

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

Cancer patients on ventilation; Healthy volunteers on ventilation

Planning 4D-CT DIAGNOSTIC_TEST

In order to perform in-silico planning, 4D-CT will be acquired on patients under non-invasive mechanically-assisted ventilation

Planning with patients on ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No comorbidity for healthy volunteers
• Cancer patients with either lung or upper abdomen (liver/pancreas) tumours treated with radiation therapy.

You may not qualify if:

• severe lung disease or emphysema
• previous history of pneumothorax
• claustrophobia

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Thoracic Neoplasms; Liver Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Xavier Geets, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 24, 2017
• Study Start: June 30, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: July 15, 2019

Record last verified: 2019-07

Locations

BE (1)