Motion of Kids on Radiation Treatment

March 12, 2024 updated by: University Health Network, Toronto

Paediatric and Adolescent Radiotherapy Without Anaesthesia Using Audio-Visual Distraction - Are the Patients Moving?

At Princess Margaret Cancer Centre, a comprehensive approach to help children stay still during radiation treatment (RT) such as audio-visual distraction (television) is routinely used. These techniques help reduce the need for sedation or general anaesthesia to keep children still to avoid the chance of missing the tumour during RT. This approach has not been systematically evaluated to determine its effectiveness at reducing movement of children receiving RT. The purpose of the study is to measure the movement of children between the beginning and the end of RT to see how much they moved during treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cone beam CT (CBCT) is a low-dose imaging technique routinely used at Princess Margaret Cancer Centre to check the position of patients before RT. Using CBCT, the doctor is able to reduce the amount of tissues that receive RT because patients can be set-up with greater accuracy to only target the tumour and not harm the surrounding healthy tissue. In this study, children will receive one CBCT scan before starting RT as part of standard approach. Then after RT, another CBCT scan will be used to measure movement between the beginning and end of RT. The information gathered from this study will benefit other patients and cancer centres in the future, who can learn from these methods of using audio-visual distraction so that children have minimal or no motion for a more precise delivery of radiation during cancer treatment.

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Paediatric patients receiving an existing multi-faceted approach to reduce anaesthesia use in paediatric and adolescent radiotherapy (RT)

Description

Inclusion Criteria:

  • Patient (paediatric or adolescent) age 18 or under receiving RT without anaesthetic or procedural sedation (anaesthetic gas or intravenous sedative medication)

Exclusion Criteria:

  • Patients receiving oral midazolam or ketamine are ineligible
  • Patient is receiving total body irradiation without CBCT

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients that move between pre- and post-RT CBCT acquisitions without anaesthesia.
Time Frame: 12 months
To determine the proportion of patients with adequate immobilization by measuring motion between pre- and post-RT CBCT acquisitions for patients treated without anaesthesia
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative intra-fraction motion of patients treated with RT without anaesthesia.
Time Frame: 12 months
To quantitatively determine intra-fraction motion of patients treated with RT without anaesthesia
12 months
Factors associated with intra-fraction patient motion.
Time Frame: 12 months
To evaluate factors associated with intra-fraction patient motion, thus facilitating creation of individualized, patient-specific planning target volumes (PTV)
12 months
Perturbations in delivered treatment dose.
Time Frame: 12 months
To calculate perturbations in delivered treatment dose using dose-accumulation upon on-treatment CBCT images
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Derek Tsang, MD, FRCPC, Princess Margaret Cancer Centre, University Health Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2019

Primary Completion (Actual)

February 5, 2024

Study Completion (Actual)

February 5, 2024

Study Registration Dates

First Submitted

June 19, 2019

First Submitted That Met QC Criteria

June 19, 2019

First Posted (Actual)

June 24, 2019

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • UHN REB 18-5370

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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