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Completed

NCT Number: NCT03995849

Motion of Kids on Radiation Treatment

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.

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Key information

Conditions

Observational Study

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

About this study

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.

Who can participate

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

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

Treatment and study plan

Cone Beam CT Scan

Diagnostic Test

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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)

  3. Perturbations in delivered treatment dose.

    Time frame: 12 months

    To calculate perturbations in delivered treatment dose using dose-accumulation upon on-treatment CBCT images

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jun 24, 2019
Registry last updated
Mar 15, 2024

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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