Observational StudyNCT03995849
Motion of Kids on Radiation Treatment
An observational study of Observational Study, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Observational Study
- What is being tested?
- Cone Beam CT Scan
- How many people
- 65 participants
- Where
- 1 siteCanada
- Study dates
- 29 Oct 2019to 5 Feb 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Child, Adult
Study population: Paediatric patients receiving an existing multi-faceted approach to reduce anaesthesia use in paediatric and adolescent radiotherapy (RT)
Who may be able to join
- Patient (paediatric or adolescent) age 18 or under receiving RT without anaesthetic or procedural sedation (anaesthetic gas or intravenous sedative medication)
Who cannot join
- Patients receiving oral midazolam or ketamine are ineligible
- Patient is receiving total body irradiation without CBCT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Observational Study
- Being tested
- Cone Beam CT Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cone Beam CT ScanDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Patients That Move Between Pre- and Post-RT CBCT Acquisitions Without Anaesthesia.
To determine the proportion of patients with adequate immobilization by measuring motion between pre- and post-RT CBCT acquisitions for patients treated without anaesthesia. The threshold for minimal movement is stratified for body site, as HN treatments are below 3mm and 5mm for non-HN treatments. The total number of fractions adequately immobilized (movement less than threshold) is calculated by the mean value in percentage per body site.
Measured: 12 months
Secondary outcomes (3)
Quantitative Intra-fraction Motion of Patients Treated With RT Without Anaesthesia.
To quantitatively determine intra-fraction motion of patients treated with RT without anaesthesia. Median movement stratified by body site.
Measured: 12 months
Factors Associated With Intra-fraction Patient Motion.
To evaluate factors associated with intra-fraction patient motion, thus facilitating creation of individualized, patient-specific planning target volumes (PTV)
Measured: 12 months
Perturbations in Delivered Treatment Dose.
To calculate perturbations in delivered treatment dose using dose-accumulation upon on-treatment CBCT images
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start29 Oct 2019
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Observational StudyStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Derek Tsang, MD, FRCPC, Principal investigator, Princess Margaret Cancer Centre, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995849
- Sponsor's protocol ID
- 18-5370
- Status last verified
- Aug 2026
- First submitted
- 19 Jun 2019
- Last updated
- 2 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anghelescu DL, Burgoyne LL, Liu W, Hankins GM, Cheng C, Beckham PA, Shearer J, Norris AL, Kun LE, Bikhazi GB. Safe anesthesia for radiotherapy in pediatric oncology: St. Jude Children's Research Hospital Experience, 2004-2006. Int J Radiat Oncol Biol Phys. 2008 Jun 1;71(2):491-7. doi: 10.1016/j.ijrobp.2007.09.044. Epub 2008 Jan 22.
PubMed 18207663Scott MT, Todd KE, Oakley H, Bradley JA, Rotondo RL, Morris CG, Klein S, Mendenhall NP, Indelicato DJ. Reducing Anesthesia and Health Care Cost Through Utilization of Child Life Specialists in Pediatric Radiation Oncology. Int J Radiat Oncol Biol Phys. 2016 Oct 1;96(2):401-405. doi: 10.1016/j.ijrobp.2016.06.001. Epub 2016 Jun 5.
PubMed 27475669Khurmi N, Patel P, Koushik S, Daniels T, Kraus M. Anesthesia Practice in Pediatric Radiation Oncology: Mayo Clinic Arizona's Experience 2014-2016. Paediatr Drugs. 2018 Feb;20(1):89-95. doi: 10.1007/s40272-017-0259-8.
PubMed 28786083Owusu-Agyemang P, Grosshans D, Arunkumar R, Rebello E, Popovich S, Zavala A, Williams C, Ruiz J, Hernandez M, Mahajan A, Porche V. Non-invasive anesthesia for children undergoing proton radiation therapy. Radiother Oncol. 2014 Apr;111(1):30-4. doi: 10.1016/j.radonc.2014.01.016. Epub 2014 Feb 20.
PubMed 24560754Seiler G, De Vol E, Khafaga Y, Gregory B, Al-Shabanah M, Valmores A, Versteeg D, Ellis B, Mustafa MM, Gray A. Evaluation of the safety and efficacy of repeated sedations for the radiotherapy of young children with cancer: a prospective study of 1033 consecutive sedations. Int J Radiat Oncol Biol Phys. 2001 Mar 1;49(3):771-83. doi: 10.1016/s0360-3016(00)01357-2.
PubMed 11172961Letourneau D, Wong JW, Oldham M, Gulam M, Watt L, Jaffray DA, Siewerdsen JH, Martinez AA. Cone-beam-CT guided radiation therapy: technical implementation. Radiother Oncol. 2005 Jun;75(3):279-86. doi: 10.1016/j.radonc.2005.03.001.
PubMed 15890424Guerreiro F, Seravalli E, Janssens GO, van de Ven CP, van den Heuvel-Eibrink MM, Raaymakers BW. Intra- and inter-fraction uncertainties during IGRT for Wilms' tumor. Acta Oncol. 2018 Jul;57(7):941-949. doi: 10.1080/0284186X.2018.1438655. Epub 2018 Feb 19.
PubMed 29457751Yin FF, Wang Z, Yoo S, Wu QJ, Kirkpatrick J, Larrier N, Meyer J, Willett CG, Marks LB. Integration of cone-beam CT in stereotactic body radiation therapy. Technol Cancer Res Treat. 2008 Apr;7(2):133-9. doi: 10.1177/153303460800700206.
PubMed 18345702Richmond ND, Pilling KE, Peedell C, Shakespeare D, Walker CP. Positioning accuracy for lung stereotactic body radiotherapy patients determined by on-treatment cone-beam CT imaging. Br J Radiol. 2012 Jun;85(1014):819-23. doi: 10.1259/bjr/54341099.
PubMed 22665927
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paediatric and Adolescent Radiotherapy Without Anaesthesia Using Audio-Visual Distraction - Are the Patients Moving?
- ClinicalTrials.gov ID
- NCT03995849
- Acronym / sponsor ID
- 18-5370
- Conditions
- Observational Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 24 Jun 2019 (actual)
- Results
- Posted 2 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Paediatric patients receiving an existing multi-faceted approach to reduce anaesthesia use in paediatric and adolescent radiotherapy (RT)
Key inclusion criteria (1 listed)
- Patient (paediatric or adolescent) age 18 or under receiving RT without anaesthetic or procedural sedation (anaesthetic gas or intravenous sedative medication)
Key exclusion criteria (2 listed)
- Patients receiving oral midazolam or ketamine are ineligible
- Patient is receiving total body irradiation without CBCT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cone Beam CT ScanIn 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. | Diagnostic test | – |
Primary outcome
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. The threshold for minimal movement is stratified for body site, as HN treatments are below 3mm and 5mm for non-HN treatments. The total number of fractions adequately immobilized (movement less than threshold) is calculated by the mean value in percentage per body site.
3 secondary outcomes
Quantitative Intra-fraction Motion of Patients Treated With RT Without Anaesthesia.
Time frame: 12 months
Factors Associated With Intra-fraction Patient Motion.
Time frame: 12 months
Perturbations in Delivered Treatment Dose.
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18207663Anghelescu DL, Burgoyne LL, Liu W, Hankins GM, Cheng C, Beckham PA, Shearer J, Norris AL, Kun LE, Bikhazi GB. Safe anesthesia for radiotherapy in pediatric oncology: St. Jude Children's Research Hospital Experience, 2004-2006. Int J Radiat Oncol Biol Phys. 2008 Jun 1;71(2):491-7. doi: 10.1016/j.ijrobp.2007.09.044. Epub 2008 Jan 22.
- Background: PubMed 27475669Scott MT, Todd KE, Oakley H, Bradley JA, Rotondo RL, Morris CG, Klein S, Mendenhall NP, Indelicato DJ. Reducing Anesthesia and Health Care Cost Through Utilization of Child Life Specialists in Pediatric Radiation Oncology. Int J Radiat Oncol Biol Phys. 2016 Oct 1;96(2):401-405. doi: 10.1016/j.ijrobp.2016.06.001. Epub 2016 Jun 5.
- Background: PubMed 28786083Khurmi N, Patel P, Koushik S, Daniels T, Kraus M. Anesthesia Practice in Pediatric Radiation Oncology: Mayo Clinic Arizona's Experience 2014-2016. Paediatr Drugs. 2018 Feb;20(1):89-95. doi: 10.1007/s40272-017-0259-8.
- Background: PubMed 24560754Owusu-Agyemang P, Grosshans D, Arunkumar R, Rebello E, Popovich S, Zavala A, Williams C, Ruiz J, Hernandez M, Mahajan A, Porche V. Non-invasive anesthesia for children undergoing proton radiation therapy. Radiother Oncol. 2014 Apr;111(1):30-4. doi: 10.1016/j.radonc.2014.01.016. Epub 2014 Feb 20.
- Background: PubMed 11172961Seiler G, De Vol E, Khafaga Y, Gregory B, Al-Shabanah M, Valmores A, Versteeg D, Ellis B, Mustafa MM, Gray A. Evaluation of the safety and efficacy of repeated sedations for the radiotherapy of young children with cancer: a prospective study of 1033 consecutive sedations. Int J Radiat Oncol Biol Phys. 2001 Mar 1;49(3):771-83. doi: 10.1016/s0360-3016(00)01357-2.
- Background: PubMed 15890424Letourneau D, Wong JW, Oldham M, Gulam M, Watt L, Jaffray DA, Siewerdsen JH, Martinez AA. Cone-beam-CT guided radiation therapy: technical implementation. Radiother Oncol. 2005 Jun;75(3):279-86. doi: 10.1016/j.radonc.2005.03.001.
- Background: PubMed 29457751Guerreiro F, Seravalli E, Janssens GO, van de Ven CP, van den Heuvel-Eibrink MM, Raaymakers BW. Intra- and inter-fraction uncertainties during IGRT for Wilms' tumor. Acta Oncol. 2018 Jul;57(7):941-949. doi: 10.1080/0284186X.2018.1438655. Epub 2018 Feb 19.
- Background: PubMed 18345702Yin FF, Wang Z, Yoo S, Wu QJ, Kirkpatrick J, Larrier N, Meyer J, Willett CG, Marks LB. Integration of cone-beam CT in stereotactic body radiation therapy. Technol Cancer Res Treat. 2008 Apr;7(2):133-9. doi: 10.1177/153303460800700206.
- Background: PubMed 22665927Richmond ND, Pilling KE, Peedell C, Shakespeare D, Walker CP. Positioning accuracy for lung stereotactic body radiotherapy patients determined by on-treatment cone-beam CT imaging. Br J Radiol. 2012 Jun;85(1014):819-23. doi: 10.1259/bjr/54341099.
- Published ManuscriptLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek Tsang, MD, FRCPC principal investigator
Princess Margaret Cancer Centre, University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Observational Study, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Proportion of Patients That Move Between Pre- and Post-RT CBCT Acquisitions Without Anaesthesia. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03995849, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.