Clinical trial NCT05783908: Impact of Non-magnetic Screen Respiratory Self-guidance During MRI-guided Radiotherapy Sessions for Mobile Lesions
Official title: Impact of Non-magnetic Screen Respiratory Self-guidance During MRI-guided Radiotherapy Sessions for Mobile Lesions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patient With Radiotherapy (Linac MRI)
Mobile Cancerous Lesion
Keywords: Linac IRM
Pancreatic cancer
Liver cancer
Kidney cancer
Adrenal cancer
Lung cancer
Adenopathy above or below the diaphragm
Lead sponsor: Centre Georges Francois Leclerc
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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

Eligibility criteria: 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

Primary outcomes:
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).
timeFrame: During 25 months
Secondary outcomes:
measure: Patient respiratory effort with visual analog scale
timeFrame: During 25 months
measure: The positional pain with visual analog scale
timeFrame: During 25 months
measure: Level of anxiety/stress evaluated with the Spielberg scale via the STAI-Y-form grid
timeFrame: During 25 months
measure: The potential time
timeFrame: During 25 months
measure: The patient satisfaction evaluated with an ad-hoc questionnaire.
timeFrame: During 25 months
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Georges-François Leclerc
state: Côte d'Or
Study officials:
References: