Patient With Radiotherapy (Linac MRI)RespEcranNCT05783908
Impact of Non-magnetic Screen Respiratory Self-guidance During MRI-guided Radiotherapy Sessions for Mobile Lesions
A study testing With non-magnetic screen in people with Patient With Radiotherapy (Linac MRI) and Mobile Cancerous Lesion, run by Centre Georges Francois Leclerc at 1 site in France.
Trial summary
The patients eligible for the study are those treated by radiotherapy on Linac MRI for a mobile cancerous lesion (pancreas, liver, kidneys, adrenals, lung, adenopathy above or below the diaphragm ...). Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Patient With Radiotherapy (Linac MRI), Mobile Cancerous Lesion
- What is being tested?
- With non-magnetic screen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2023to 27 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient is at least 18 years old
- Patient starting radiotherapy on Linac MRI for a mobile cancerous lesion most often in the pancreas, liver, kidneys, adrenals, lung, supra or subdiaphragmatic adenopathy
- Patient affiliated to the social security system
Who cannot join
- Patient with lesions not detected by the device's tracking system
- Patient with visual disturbances
- Contraindications to treatment with Linac MRI (epileptic patients, pregnant or breastfeeding women, metallic prosthesis or pacemaker not compatible with MRI)
- Patients with cognitive disorders
- Persons deprived of liberty or under guardianship (including curatorship)
- Pregnant or nursing woman
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Georges-François Leclerc
Dijon, Côte d'Or, 21000
Gilles TRUC, Dr, 03 80 73 75 18 ext. +33, gtruc@cgfl.fr
Sophie PARNALLAND, Project Manager, 03 45 34 80 77 ext. +33, sparnalland@cgfl.fr
About this study
The patients eligible for the study are those treated by radiotherapy on Linac MRI for a mobile cancerous lesion (pancreas, liver, kidneys, adrenals, lung, adenopathy above or below the diaphragm ...).
After signing the consent form, each patient will be randomized to one of two treatment arms:
- Standard arm : Radiotherapy treatment with Linac MRI without non-magnetic shielding
- Experimental arm : radiotherapy treatment with Linac MRI with non-magnetic screen The aim is to evaluate the effect of using a non-magnetic screen visible to the patient in the bunker during radiotherapy sessions delivered by Linac MRI on decreasing the ratio between the actual treatment time and the treatment time predicted by the machine.
Read the detailed description
The patients eligible for the study are those treated by radiotherapy on Linac MRI for a mobile cancerous lesion (pancreas, liver, kidneys, adrenals, lung, adenopathy above or below the diaphragm ...).
After signing the consent form, each patient will be randomized to one of two treatment arms:
- Standard arm : Radiotherapy treatment with Linac MRI without non-magnetic shielding
- Experimental arm : radiotherapy treatment with Linac MRI with non-magnetic screen
The aim is to compare the effect of the non-magnetic screen on the blocking of the patient's breathing versus the current procedure (the blocking of the breathing is informed by the staff)
The patients will each receive 5 sessions of radiotherapy on Linac MRI. 100 patients are expected to participate in this study
Before each session will be assessed for anxiety and stress. After each session will be evaluated patient satisfaction, pain intensity and respiratory effort.
The duration of the treatment and therefore of the follow-up of the patient in the study is 1 to 2 weeks
- Being tested
- With non-magnetic screen
- Keywords
- Linac IRM, Pancreatic cancer, Liver cancer, Kidney cancer, Adrenal cancer, Lung cancer, Adenopathy above or below the diaphragm
- Medical subject headings
- Pancreatic Neoplasms, Liver Neoplasms, Kidney Neoplasms, Adrenal Gland Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With non-magnetic screenCombination product
Radiotherapy treatment with Linac MRI is performed with a non-magnetic screen that will guide the patient to block the breathing
| Study group | Role | What they receive |
|---|---|---|
| Without Non-magnetic screen | No intervention | Radiotherapy treatment with Linac MRI without non-magnetic shielding |
| With non-magnetic screen | Experimental | Radiotherapy treatment with Linac MRI with non-magnetic screen Receives: Combination Product: With non-magnetic screen |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of the non-magnetic screen during radiotherapy (Change in ratio of actual treatment time to the treatment time predicted by the machine).
To evaluate the effect of a non-magnetic screen visible to the patient in the bunker during radiation therapy sessions delivered by Linac MRI on decreasing the ratio of actual treatment time to the treatment time predicted by the machine.
Measured: During 25 months
Secondary outcomes (5)
Patient respiratory effort with visual analog scale
Patient respiratory effort for each radiotherapy session according to randomization arm.
The scale is graduated from 0 to 10 with 10 = maximum respiratory discomfort and 0 = no respiratory discomfort
Measured: During 25 months
The positional pain with visual analog scale
Compare the positional pain associated with setting up on the treatment table for each radiation therapy session according to the randomization arm.
The scale is graduated from 0 to 10 with 0 = absence of pain and 10 = maximum pain
Measured: During 25 months
Level of anxiety/stress evaluated with the Spielberg scale via the STAI-Y-form grid
To assess the average level of anxiety/stress for each radiation therapy session according to the randomization arm. The Spielberg scale via the STAI-form Y-A grid is used before each treatment session in order to follow the evolution of the patients' emotional state.
20 questions with 4 possible answers : 1/ Not at all, 2/ A little, 3/Moderately , 4/ A lot.
Measured: During 25 months
The potential time
Evaluate whether the potential time savings in screen time compensates for the time spent learning the screen during the simulation.
Measured: During 25 months
The patient satisfaction evaluated with an ad-hoc questionnaire.
The patient's satisfaction with his or her involvement in the treatment process will be evaluated at the end of the 5 radiotherapy sessions using an ad-hoc questionnaire.
Measured: During 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start16 Oct 2023
- Primary completion27 Sep 2025 (estimated)
- Study completion27 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient With Radiotherapy (Linac MRI)Studies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783908
- Sponsor's protocol ID
- 2022-A02774-39
- Acronym
- RespEcran
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2023
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Non-magnetic Screen Respiratory Self-guidance During MRI-guided Radiotherapy Sessions for Mobile Lesions
- ClinicalTrials.gov ID
- NCT05783908
- Acronym / sponsor ID
- RespEcran / 2022-A02774-39
- Keywords
- Linac IRM, Pancreatic cancer, Liver cancer, Kidney cancer, Adrenal cancer, Lung cancer, Adenopathy above or below the diaphragm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 27 Sep 2025 (estimated)
- Study completion
- 27 Sep 2025 (estimated)
- First posted
- 24 Mar 2023 (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.
The patients eligible for the study are those treated by radiotherapy on Linac MRI for a mobile cancerous lesion (pancreas, liver, kidneys, adrenals, lung, adenopathy above or below the diaphragm ...).
After signing the consent form, each patient will be randomized to one of two treatment arms:
- Standard arm : Radiotherapy treatment with Linac MRI without non-magnetic shielding
- Experimental arm : radiotherapy treatment with Linac MRI with non-magnetic screen The aim is to evaluate the effect of using a non-magnetic screen visible to the patient in the bunker during radiotherapy sessions delivered by Linac MRI on decreasing the ratio between the actual treatment time and the treatment time predicted by the machine.
Detailed description
The patients eligible for the study are those treated by radiotherapy on Linac MRI for a mobile cancerous lesion (pancreas, liver, kidneys, adrenals, lung, adenopathy above or below the diaphragm ...).
After signing the consent form, each patient will be randomized to one of two treatment arms:
- Standard arm : Radiotherapy treatment with Linac MRI without non-magnetic shielding
- Experimental arm : radiotherapy treatment with Linac MRI with non-magnetic screen
The aim is to compare the effect of the non-magnetic screen on the blocking of the patient's breathing versus the current procedure (the blocking of the breathing is informed by the staff)
The patients will each receive 5 sessions of radiotherapy on Linac MRI. 100 patients are expected to participate in this study
Before each session will be assessed for anxiety and stress. After each session will be evaluated patient satisfaction, pain intensity and respiratory effort.
The duration of the treatment and therefore of the follow-up of the patient in the study is 1 to 2 weeks
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without Non-magnetic screen | No intervention | –Radiotherapy treatment with Linac MRI without non-magnetic shielding |
| With non-magnetic screen | Experimental | Combination Product: With non-magnetic screenRadiotherapy treatment with Linac MRI with non-magnetic screen |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is at least 18 years old
- Patient starting radiotherapy on Linac MRI for a mobile cancerous lesion most often in the pancreas, liver, kidneys, adrenals, lung, supra or subdiaphragmatic adenopathy
- Patient affiliated to the social security system
Key exclusion criteria (7 listed)
- Patient with lesions not detected by the device's tracking system
- Patient with visual disturbances
- Contraindications to treatment with Linac MRI (epileptic patients, pregnant or breastfeeding women, metallic prosthesis or pacemaker not compatible with MRI)
- Patients with cognitive disorders
- Persons deprived of liberty or under guardianship (including curatorship)
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 |
|---|---|---|
| With non-magnetic screenRadiotherapy treatment with Linac MRI is performed with a non-magnetic screen that will guide the patient to block the breathing | Combination product | With non-magnetic screen |
Primary outcome
The effect of the non-magnetic screen during radiotherapy (Change in ratio of actual treatment time to the treatment time predicted by the machine).
Time frame: During 25 months
To evaluate the effect of a non-magnetic screen visible to the patient in the bunker during radiation therapy sessions delivered by Linac MRI on decreasing the ratio of actual treatment time to the treatment time predicted by the machine.
5 secondary outcomes
Patient respiratory effort with visual analog scale
Time frame: During 25 months
The positional pain with visual analog scale
Time frame: During 25 months
Level of anxiety/stress evaluated with the Spielberg scale via the STAI-Y-form grid
Time frame: During 25 months
The potential time
Time frame: During 25 months
The patient satisfaction evaluated with an ad-hoc questionnaire.
Time frame: During 25 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing With non-magnetic screen in people with Patient With Radiotherapy (Linac MRI) and Mobile Cancerous Lesion, run by Centre Georges Francois Leclerc at 1 site in France.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 17 Feb 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gilles TRUC, Doctor (03 80 73 75 18 ext. +33, gtruc@cgfl.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of the non-magnetic screen during radiotherapy (Change in ratio of actual treatment time to the treatment time predicted by the machine). (time frame: During 25 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 17 Feb 2025.