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

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.

Study Overview

• Status: Recruiting
• Conditions: Patient With Radiotherapy (Linac MRI); Mobile Cancerous Lesion
• Intervention / Treatment: Combination product: With non-magnetic screen

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

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gilles TRUC, Doctor; Phone Number: +33 03 80 73 75 18; Email: gtruc@cgfl.fr
• Study Contact Backup: Name: Sophie PARNALLAND, Project Manager; Phone Number: +33 03 45 34 80 77; Email: sparnalland@cgfl.fr

Study Locations

• France
  • Côte d'Or
    • Dijon, Côte d'Or, France, 21000
      • Recruiting
      • Centre Georges-François Leclerc
      • Contact: Sophie PARNALLAND, Project Manager; Phone Number: +33 03 45 34 80 77; Email: sparnalland@cgfl.fr
      • Contact: Gilles TRUC, Dr; Phone Number: +33 03 80 73 75 18; Email: gtruc@cgfl.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Without Non-magnetic screen; Radiotherapy treatment with Linac MRI without non-magnetic shielding
Experimental: With non-magnetic screen; Radiotherapy treatment with Linac MRI with non-magnetic screen	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Georges Francois Leclerc

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Estimated): September 27, 2025
• Study Completion (Estimated): September 27, 2025

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Lung cancer; Kidney cancer; Pancreatic cancer; Liver cancer; Adrenal cancer; Linac IRM; Adenopathy above or below the diaphragm
• Other Study ID Numbers: 2022-A02774-39

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No