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Motion of Kids on Radiation Treatment

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03995849
Enrollment
65
Registered
2019-06-24
Start date
2019-10-29
Completion date
2024-02-05
Last updated
2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Observational Study

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.

Interventions

DIAGNOSTIC_TESTCone Beam CT Scan

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.

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years

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

Design outcomes

Primary

MeasureTime frameDescription
The proportion of patients that move between pre- and post-RT CBCT acquisitions without anaesthesia.12 monthsTo determine the proportion of patients with adequate immobilization by measuring motion between pre- and post-RT CBCT acquisitions for patients treated without anaesthesia

Secondary

MeasureTime frameDescription
Quantitative intra-fraction motion of patients treated with RT without anaesthesia.12 monthsTo quantitatively determine intra-fraction motion of patients treated with RT without anaesthesia
Factors associated with intra-fraction patient motion.12 monthsTo 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 monthsTo calculate perturbations in delivered treatment dose using dose-accumulation upon on-treatment CBCT images

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026