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Trial Title:
Impact of Non-magnetic Screen Respiratory Self-guidance During MRI-guided Radiotherapy Sessions for Mobile Lesions
NCT ID:
NCT05783908
Condition:
Patient With Radiotherapy (Linac MRI)
Mobile Cancerous Lesion
Conditions: Keywords:
Linac IRM
Pancreatic cancer
Liver cancer
Kidney cancer
Adrenal cancer
Lung cancer
Adenopathy above or below the diaphragm
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Participant)
Intervention:
Intervention type:
Combination Product
Intervention name:
With non-magnetic screen
Description:
Radiotherapy treatment with Linac MRI is performed with a non-magnetic screen that will
guide the patient to block the breathing
Arm group label:
With non-magnetic screen
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
Criteria for 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
Gender:
All
Minimum age:
18 Months
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Georges-François Leclerc
Address:
City:
Dijon
Zip:
21000
Country:
France
Status:
Recruiting
Contact:
Last name:
Gilles TRUC, Dr
Phone:
03 80 73 75 18
Phone ext:
+33
Email:
gtruc@cgfl.fr
Contact backup:
Last name:
Sophie PARNALLAND, Project Manager
Phone:
03 45 34 80 77
Phone ext:
+33
Email:
sparnalland@cgfl.fr
Start date:
October 16, 2023
Completion date:
September 27, 2025
Lead sponsor:
Agency:
Centre Georges Francois Leclerc
Agency class:
Other
Source:
Centre Georges Francois Leclerc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05783908
