Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06240559
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-01-26
Brief Title:
In Vivo Treatment Verification of Brachytherapy
Sponsor:
Maastricht Radiation Oncology
Organization:
Maastricht Radiation Oncology
Study Overview
Official Title:
In-vivo Treatment Verification for HDR Brachytherapy Patients Using an External Imaging Panel
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To acquire data during High Dose Rate HDR brachytherapy treatments aiming to track the brachytherapy source inside the patient verifying the delivery of the treatment plan
Medical images CTMRI and US combined with software developed by the investigator will be employed to predict the response of the Investigational product during the treatment and will be used as referenceThe IP will be placed on the side of the treatment table and will acquire data during the whole treatment which will be compared against information derived from the treatment plan The IP based method can detect errors and information about motion and treatment uncertainties that are not currently available
Medical images CTMRI and US combined with software developed by the investigator will be employed to predict the response of the Investigational product during the treatment and will be used as referenceThe IP will be placed on the side of the treatment table and will acquire data during the whole treatment which will be compared against information derived from the treatment plan The IP based method can detect errors and information about motion and treatment uncertainties that are not currently available
Detailed Description:
Medical images CTMRI and US combined with software developed by us will be employed to predict the response of the IP during the treatment and will be used as reference The IP will be placed on the side of the treatment table and will acquire data during the whole treatment which will be compared against information derived from the treatment plan The IP based method can detect errors and information about motion and treatment uncertainties that are not currently available
The IP will not change the workflow or be in contact with the patient since the panel will be placed on the side of a treatment tablebed at a safe distance from the patient The data will be acquired automatically when radiation is detected and only two cables are necessary to power the system and collect the data The cables will be placed in a convenient position together with the cables of the treatment table not interfering with the clinical workflow Clinical staff will not need to perform any extra actions during the whole process of the data acquisition
The analysis of the data generated during the trial will be performed offline to avoid a possible interruption of the treatment due to any error real or false that may be detected using the system
The IP will not change the workflow or be in contact with the patient since the panel will be placed on the side of a treatment tablebed at a safe distance from the patient The data will be acquired automatically when radiation is detected and only two cables are necessary to power the system and collect the data The cables will be placed in a convenient position together with the cables of the treatment table not interfering with the clinical workflow Clinical staff will not need to perform any extra actions during the whole process of the data acquisition
The analysis of the data generated during the trial will be performed offline to avoid a possible interruption of the treatment due to any error real or false that may be detected using the system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None