Motion of Kids on Radiation Treatment

Completed

• Conditions: Observational Study

• Registration Number: NCT03995849
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

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 Timeline

• Study First Submitted: 2019-06-19
• Study First Submitted QC: 2019-06-19
• Study First Posted: 2019-06-24
• Study Start: 2019-10-29
• Primary Completion: 2024-02-05
• Study Completion: 2024-02-05
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients that move between pre- and post-RT CBCT acquisitions without anaesthesia.	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 Outcome Measures

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

Trial Locations

Locations (1)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada