In Vivo Treatment Verification of Brachytherapy

NCT ID: NCT06240559

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-29

Study Completion Date

2026-02-28

Brief Summary

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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

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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.

Conditions

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Brachytherapy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht Radiation Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maaike Berbée

Role: PRINCIPAL_INVESTIGATOR

Radiotherapist

Locations

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Maastro

Maastricht, Limburg, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Janneke Waelen

Role: CONTACT

+31 88 445 5334

Other Identifiers

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Verification of brachytherapy

Identifier Type: -

Identifier Source: org_study_id

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