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Motion of Kids on Radiation Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03995849
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Observational Study Diagnostic Test: Cone Beam CT Scan

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.

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Study Type : Observational
Estimated Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Paediatric and Adolescent Radiotherapy Without Anaesthesia Using Audio-Visual Distraction - Are the Patients Moving?
Actual Study Start Date : October 29, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Quantitative intra-fraction motion of patients treated with RT without anaesthesia. [ Time Frame: 12 months ]
    To quantitatively determine intra-fraction motion of patients treated with RT without anaesthesia

  2. Factors associated with intra-fraction patient motion. [ Time Frame: 12 months ]
    To evaluate factors associated with intra-fraction patient motion, thus facilitating creation of individualized, patient-specific planning target volumes (PTV)

  3. Perturbations in delivered treatment dose. [ Time Frame: 12 months ]
    To calculate perturbations in delivered treatment dose using dose-accumulation upon on-treatment CBCT images



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995849


Contacts
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Contact: Derek Tsang, MD, FRCPC 416-946-2121 Derek.Tsang@rmp.uhn.ca
Contact: Tatiana Ritchie, BSc, MRT(T) 416-946-4501 ext 8812 Tatiana.Ritchie@rmp.uhn.ca

Locations
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Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Derek Tsang, MD    4169464501 ext 2121    Derek.Tsang@rmp.uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Derek Tsang, MD, FRCPC Princess Margaret Cancer Centre, University Health Network
Publications:

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03995849    
Other Study ID Numbers: UHN REB 18-5370
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No