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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03226925
Enrollment
23
Registered
2017-07-24
Start date
2017-06-30
Completion date
2019-06-01
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

thoracic tumors, motion management, radiotherapy, ventilator

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.

Interventions

DIAGNOSTIC_TESTNon-invasive mechanically-assisted ventilation

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

DIAGNOSTIC_TESTDynamic MRI acquisition

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

DIAGNOSTIC_TESTPlanning 4D-CT

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

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Measure in millimeters of the internal motion during non-invasive mechanically assisted ventilation, based on MRI imageswithin 12 monthsThis 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

MeasureTime frameDescription
Tolerance assessmentwithin 12 monthsDuring all these acquisitions, the tolerance to the non-invasive mechanically assisted ventilation will be assessed by all the participants through a 5-steps scale.
Internal motion reproducibility with non-invasive mechanically assisted ventilation.Within 12 monthsThis 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.
Dosimetric comparisonwithin 12 monthsThis 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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026