In Vivo Treatment Verification of Brachytherapy
- Conditions
- Brachytherapy
- Registration Number
- NCT06240559
- Lead Sponsor
- Maastricht Radiation Oncology
- 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 (CT,MRI 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 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.
- Detailed Description
Medical images (CT,MRI 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 table/bed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Treatment site Gynaecology (Endometrium/Cervix) and prostate
- Treatment: HDR Brachytherapy
- Patient will be treated on CT Couch
- Mentally competent patient
- Incapacitated patient
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dwell position 1 year Verify all relevant parameters of the HDR treatment plan during treatment delivery such as dwell positions (distance in (milli)meters).
Brachytherapy treatments are delivered using two parameters, the second parameter is dwell positions (a location where the radioactive source should stop, defined in centimeters (cm)) Our system measures dwell positions, comparing them against expected values. Note that this parameter can be further used to derive other metrics, such as radiation dose distributions (units in Gray (Gy)), as defined by the TG-43 AAPM dose formalism.Dwell times 1 year Verify all relevant parameters of the HDR treatment plan during treatment delivery such as dwell times (time in seconds).
Brachytherapy treatments are delivered using two parameters, the first parameter is dwell times (the duration the radioactive source stays in a dwell position, measured in seconds (s)). Our system measures dwell times, comparing them against expected values. Note that this parameter can be further used to derive other metrics, such as radiation dose distributions (units in Gray (Gy)), as defined by the TG-43 AAPM dose formalism.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Maastro
🇳🇱Maastricht, Limburg, Netherlands