Impact of Non-magnetic Screen Respiratory Self-guidance During MRI-guided Radiotherapy Sessions for Mobile Lesions
NCT ID: NCT05783908
Last Updated: 2025-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-10-16
2025-09-27
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Without Non-magnetic screen
Radiotherapy treatment with Linac MRI without non-magnetic shielding
No interventions assigned to this group
With non-magnetic screen
Radiotherapy treatment with Linac MRI with non-magnetic screen
With non-magnetic screen
Radiotherapy treatment with Linac MRI is performed with a non-magnetic screen that will guide the patient to block the breathing
Interventions
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With non-magnetic screen
Radiotherapy treatment with Linac MRI is performed with a non-magnetic screen that will guide the patient to block the breathing
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Months
ALL
No
Sponsors
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Centre Georges Francois Leclerc
OTHER
Responsible Party
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Locations
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Centre Georges-François Leclerc
Dijon, Côte d'Or, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-A02774-39
Identifier Type: -
Identifier Source: org_study_id
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