Motion of Kids on Radiation Treatment

NCT03995849 | Completed

• 1 other identifier: UHN REB 18-5370
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Observational Study

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (3)

• Quantitative intra-fraction motion of patients treated with RT without anaesthesia.

  12 months

• Factors associated with intra-fraction patient motion.

  12 months

• Perturbations in delivered treatment dose.

  12 months

Interventions

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.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (9)

• 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.

  PMID: 18207663 BACKGROUND

• Scott 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.

  PMID: 27475669 BACKGROUND

• Khurmi 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.

  PMID: 28786083 BACKGROUND

• Owusu-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.

  PMID: 24560754 BACKGROUND

• Seiler 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.

  PMID: 11172961 BACKGROUND

• Letourneau 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.

  PMID: 15890424 BACKGROUND

• Guerreiro 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.

  PMID: 29457751 BACKGROUND

• Yin 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.

  PMID: 18345702 BACKGROUND

• Richmond 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.

  PMID: 22665927 BACKGROUND

Related Links

• Published Manuscript

MeSH Terms

Interventions

Tomography, Spiral Computed

Intervention Hierarchy (Ancestors)

Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Derek Tsang, MD, FRCPC

  Princess Margaret Cancer Centre, University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 24, 2019
• Study Start: October 29, 2019
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)