Motion of Kids on Radiation Treatment

Observational Study Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03995849
• Other study ID #: UHN REB 18-5370
• Status: Completed
• Start date: October 29, 2019
• Est. completion date: February 5, 2024

Study information

• Verified date: March 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 5, 2024
• Est. primary completion date: February 5, 2024
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Observational Study

Intervention

Diagnostic Test:
• Cone 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.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quantitative intra-fraction motion of patients treated with RT without anaesthesia.	To quantitatively determine intra-fraction motion of patients treated with RT without anaesthesia	12 months
Secondary	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)	12 months
Secondary	Perturbations in delivered treatment dose.	To calculate perturbations in delivered treatment dose using dose-accumulation upon on-treatment CBCT images	12 months

External Links

•   Published Manuscript