In Vivo Treatment Verification of Brachytherapy

Brachytherapy Clinical Trial

Official title:

In-vivo Treatment Verification for HDR Brachytherapy Patients Using an External Imaging Panel

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06240559
• Other study ID #: Verification of brachytherapy
• Status: Recruiting
• Start date: February 29, 2024
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: Maastricht Radiation Oncology
• Contact: Janneke Waelen
• Phone: +31 88 445 5334
• Email: janneke.waelen[@]maastro.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Treatment site Gynaecology (Endometrium/Cervix) and prostate

• Treatment: HDR Brachytherapy

• Patient will be treated on CT Couch

• Mentally competent patient

Exclusion Criteria:

• Incapacitated patient

Related Conditions & MeSH terms

• Brachytherapy

Intervention

Device:
• External imaging panel
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.

Locations

Country	Name	City	State
Netherlands	Maastro	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dwell times	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.	1 year
Primary	Dwell position	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.	1 year