In Vivo Treatment Verification of Brachytherapy

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.

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Key information

Conditions

Brachytherapy

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastro

Maastricht, Limburg, 6229 ET, Netherlands

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

External imaging panel

Device

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.

Primary outcomes

Dwell times

Time frame: 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.
Dwell position

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Janneke Waelen

CONTACT

[email protected]

+31 88 445 5334

Sponsors and collaborators

Lead sponsor

Maastricht Radiation Oncology

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Feb 5, 2024
Registry last updated: May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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