Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627075
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Optical Surface Guidance for External Radiotherapy of Head and Neck Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility of Surface Optical Guidance to Replace the Restraint Mask for External Radiotherapy of Head and Neck Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUGAR
Brief Summary:
The goal of this clinical trial is to test the use of surface repositioning alone without a restraint mask during radiotherapy sessions for patients with head and neck cancer
Detailed Description:
In radiotherapy treatments for head and neck cancer the use of a mask is recommended for patient immobilization The mask completely covers the head and shoulders ensuring reproducible positioning at every session However using a mask can be oppressive and anxiety-provoking for patients
At the same time technological developments have led us to use optical surface camera systems to position and monitor patients in the treatment room In this way if a movement exceeding the threshold is detected during a session the treatment is automatically interrupted
However despite the use of the mask movements are still possible underneath and are not detected by the surface cameras
The studys hypothesis is that the use of surface repositioning alone could guarantee reproducible treatment as in combination with a thermoformed mask In addition eliminating the mask would mean greater comfort and improved quality of life for patients
At the same time technological developments have led us to use optical surface camera systems to position and monitor patients in the treatment room In this way if a movement exceeding the threshold is detected during a session the treatment is automatically interrupted
However despite the use of the mask movements are still possible underneath and are not detected by the surface cameras
The studys hypothesis is that the use of surface repositioning alone could guarantee reproducible treatment as in combination with a thermoformed mask In addition eliminating the mask would mean greater comfort and improved quality of life for patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None