Thoracic NeoplasmNCT03226925
Mechanically-assisted Ventilation in the Treatment of Moving Tumours With Photon and Proton Therapies
A study testing Non-invasive mechanically-assisted ventilation, Dynamic MRI acquisition and Planning 4D-CT in people with Thoracic Neoplasm and Liver Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thoracic Neoplasm, Liver Cancer, Ventilator Lung
- What is being tested?
- Non-invasive mechanically-assisted ventilation, Dynamic MRI acquisition and Planning 4D-CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Jun 2017to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No comorbidity for healthy volunteers
- Cancer patients with either lung or upper abdomen (liver/pancreas) tumours treated with radiation therapy.
Who cannot join
- severe lung disease or emphysema
- previous history of pneumothorax
- claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Added Value of Mechanically-assisted Ventilation in the Treatment of Moving Tumours (Thoracic/Upper Abdomen) 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.
Read the 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.
- Being tested
- Non-invasive mechanically-assisted ventilation, Dynamic MRI acquisition, Planning 4D-CT
- Keywords
- thoracic tumors, motion management, radiotherapy, ventilator
- Medical subject headings
- Thoracic Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive mechanically-assisted ventilationDiagnostic test
Mechanically ventilation will be done through facial masks connected to a respirator. Volunteers/patients are fully conscious during the ventilation.
Dynamic MRI acquisitionDiagnostic 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-CTDiagnostic test
In order to perform in-silico planning, 4D-CT will be acquired on patients under non-invasive mechanically-assisted ventilation
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Diagnostic Test: Non-invasive mechanically-assisted ventilation; Diagnostic Test: Planning 4D-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 12 months
Secondary outcomes (3)
Tolerance assessment
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.
Measured: within 12 months
Internal motion reproducibility with non-invasive mechanically assisted ventilation.
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.
Measured: Within 12 months
Dosimetric comparison
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.
Measured: within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start30 Jun 2017
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic NeoplasmStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- One group of patients with healthy volunteers and two groups with lung/upper abdomen cancer patients
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Geets, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226925
- Sponsor's protocol ID
- 2017/23MAI/294
- Status last verified
- Jul 2019
- First submitted
- 27 Jun 2017
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided at this moment
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Added Value of Mechanically-assisted Ventilation in the Treatment of Moving Tumours (Thoracic/Upper Abdomen) With Photon and Proton Therapies.
- ClinicalTrials.gov ID
- NCT03226925
- Acronym / sponsor ID
- 2017/23MAI/294
- Keywords
- thoracic tumors, motion management, radiotherapy, ventilator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- One group of patients with healthy volunteers and two groups with lung/upper abdomen cancer patients
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers on ventilation | Experimental | Diagnostic Test: Non-invasive mechanically-assisted ventilation, Diagnostic Test: Dynamic MRI acquisitionDynamic 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). |
| Cancer patients on ventilation | Experimental | Diagnostic Test: Non-invasive mechanically-assisted ventilation, Diagnostic Test: Dynamic MRI acquisitionDynamic 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). |
| Planning with patients on ventilation | Experimental | Diagnostic Test: Non-invasive mechanically-assisted ventilation, Diagnostic Test: Planning 4D-CTPlanning 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- No comorbidity for healthy volunteers
- Cancer patients with either lung or upper abdomen (liver/pancreas) tumours treated with radiation therapy.
Key exclusion criteria (3 listed)
- severe lung disease or emphysema
- previous history of pneumothorax
- claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive mechanically-assisted ventilationMechanically ventilation will be done through facial masks connected to a respirator. Volunteers/patients are fully conscious during the ventilation. | Diagnostic test | Cancer patients on ventilation, Healthy volunteers on ventilation, Planning with patients on ventilation |
| Dynamic MRI acquisitionDynamic 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 test | Cancer patients on ventilation, Healthy volunteers on ventilation |
| Planning 4D-CTIn order to perform in-silico planning, 4D-CT will be acquired on patients under non-invasive mechanically-assisted ventilation | Diagnostic test | Planning with patients on ventilation |
Primary outcome
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.
3 secondary outcomes
Tolerance assessment
Time frame: within 12 months
Internal motion reproducibility with non-invasive mechanically assisted ventilation.
Time frame: Within 12 months
Dosimetric comparison
Time frame: within 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Individual participant dataSharing planned: Undecided. Not decided at this moment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Geets, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive mechanically-assisted ventilation, Dynamic MRI acquisition and Planning 4D-CT in people with Thoracic Neoplasm and Liver Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure in millimeters of the internal motion during non-invasive mechanically assisted ventilation, based on MRI images (time frame: within 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.