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

Centre Georges Francois Leclerc

Status

Enrolling

Conditions

Patient With Radiotherapy (Linac MRI)

Mobile Cancerous Lesion

Treatments

Combination Product: With non-magnetic screen

Study type

Interventional

Funder types

Other

Identifiers

NCT05783908

2022-A02774-39

Details and patient eligibility

About

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.

Full description

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

Enrollment

100 estimated patients

Sex

All

Ages

18+ months old

Volunteers

No Healthy Volunteers

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