In Vivo Treatment Verification of Brachytherapy

NCT06240559 | Recruiting

• 1 other identifier: Verification of brachytherapy
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Brachytherapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Interventions

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Treatment site Gynaecology (Endometrium/Cervix) and prostate
• Treatment: HDR Brachytherapy
• Patient will be treated on CT Couch
• Mentally competent patient

You may not qualify if:

• Incapacitated patient

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead

Study Sites (1)

Maastro

Maastricht, Limburg, 6229 ET, Netherlands

RECRUITING

Study Officials

• Maaike Berbée

  Radiotherapist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janneke Waelen

CONTACT

+31 88 445 5334; janneke.waelen@maastro.nl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 5, 2024
• Study Start: February 29, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)