Impact of Non-magnetic Screen Respiratory Self-guidance During MRI-guided Radiotherapy Sessions for Mobile Lesions

Study Overview
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Brief Summary
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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
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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

Official Title
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Impact of Non-magnetic Screen Respiratory Self-guidance During MRI-guided Radiotherapy Sessions for Mobile Lesions

Conditions
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Patient With Radiotherapy (Linac MRI), Mobile Cancerous Lesion

Intervention / Treatment
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* Combination Product: With non-magnetic screen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Without Non-magnetic screen<br>Radiotherapy treatment with Linac MRI without non-magnetic shielding | |
| Experimental: With non-magnetic screen<br>Radiotherapy treatment with Linac MRI with non-magnetic screen | Combination Product: With non-magnetic screen<br>* Radiotherapy treatment with Linac MRI is performed with a non-magnetic screen that will guide the patient to block the breathing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During 25 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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. | 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. | 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. | During 25 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer, Linac IRM, Pancreatic cancer, Liver cancer, Kidney cancer, Adrenal cancer, Adenopathy above or below the diaphragm