NCT05783908

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Centre Georges Francois Leclerc · Academic / Other
• Sex: All
• Age: 18 Months
• Healthy volunteers: Not accepted

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 ...). 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

Conditions

• Patient With Radiotherapy (Linac MRI)
• Mobile Cancerous Lesion

Interventions

Type	Name	Description
COMBINATION_PRODUCT	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

Timeline

• Start date: 2023-10-16
• Primary completion: 2025-09-27
• Completion: 2025-09-27
• First posted: 2023-03-24
• Last updated: 2025-02-17

Locations

1 site across 1 country: France