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NCT Number: NCT03226925

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

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.

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Key information

Conditions

Thoracic Neoplasm Digestive System Diseases Digestive System Neoplasms Liver Cancer Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site Radiotherapy; Complications Thoracic Neoplasms Ventilator Lung

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

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

Primary outcomes

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

    Time frame: within 12 months

    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.

Secondary outcomes

  1. Tolerance assessment

    Time frame: within 12 months

    During all these acquisitions, the tolerance to the non-invasive mechanically assisted ventilation will be assessed by all the participants through a 5-steps scale.

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

    Time frame: Within 12 months

    This analysis will be done by comparing the motion of the internal structures/tumors at two different time points (MRI acquisition at two different time points). All these acquisitions will obviously be done in the same conditions on non-invasive mechanically assisted ventilation. Motion reproducibility will be analysed by comparing the baseline positions of anatomical structures/tumors on MRI images and the measures in millimeters of motion of the same anatomical structures/tumors.

  3. Dosimetric comparison

    Time frame: within 12 months

    This dosimetric comparison will be done in order to assess the impact of non-invasive mechanically-assisted ventilation on dose planning and delivery. Difference in dose (in Gy) to organ at risks will specially be compared through the DVH (dose-volume histogram) analysis.

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

Added Value of Mechanically-assisted Ventilation in the Treatment of Moving Tumours (Thoracic/Upper Abdomen) With Photon and Proton Therapies.

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 24, 2017
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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