Clinical trial NCT06240559: In Vivo Treatment Verification of Brachytherapy
Official title: In-vivo Treatment Verification for HDR Brachytherapy Patients Using an External Imaging Panel
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brachytherapy
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The developed method is expected to work for all treatments sites. However, HDR gynecological and prostate treatments are our main interest since they are the most common HDR treatments at Maastro.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dwell times
timeFrame: 1 year
measure: Dwell position
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastro
state: Limburg
Study officials:
affiliation: Radiotherapist
name: Maaike Berbée
role: PRINCIPAL_INVESTIGATOR
References: