Simulated Radiotherapy Treatment Assisted With Pediatric Radiation Oncology With Movie Induced Sedation Effect Technique

Simulated Radiotherapy Treatment Assisted With Pediatric Radiation Oncology With Movie Induced Sedation Effect (PROMISE) Technique

Pediatric patient will watch age-proper movie during radiation treatment. The motion of pedi-patient will continually be monitored by an AlignRT system (VisionRT LTD, UK).

Study Overview

• Status: Withdrawn
• Conditions: Childhood Cancer
• Intervention / Treatment: Device: AlignRT system (VisionRT LTD, UK)

Detailed Description

For most pediatric cancer patients under 7 years of age, current standard radiotherapy practice involves the use of anesthesia or sedation at each fraction to ensure that the patient remains still during the treatment. A child may receive up to 30 episodes of anesthesia in succession. This also means that, for the 6-week duration of radiotherapy, a child may never fully return to his/her baseline activity. More importantly, the excessive use of anesthesia introduces many risks and side effects that, combined with chemotherapy, and cancer itself, can greatly reduce the overall treatment experience for the children and their families

In the two years, the investigators have been actively developing technologies to facilitate a novel pediatric radiotherapy, which called Pediatric Radiation Oncology with Movie Induced Sedation Effect (PROMISE). The main idea of PROMISE is that pediatric patient will watch age-proper movie during radiation treatment. The motion of pediatric patient will continually be monitored by an AlignRT system (VisionRT LTD, UK). Both movie and radiation beam will be paused if the motion of pediatric patient is beyond positioning accuracy threshold. Movie and beam will be resumed if pediatric patient is positioning with in tolerance.

In this study, the investigators will use the developed PROMISE software and hardware platform to evaluate the feasibility of non-sedated radiotherapy treatment.

The investigator will use radio to mimic radiation beam delivery and gantry motion to mimic radiation device rotation. Pediatric patient will watch an age-appropriate movie of his/her choice. AlignRT (VisionRT LTD, UK) imaging system will be used to monitor the motion of the patient. If the motion exceeds any pre-defined positioning thresholds the sound mimic treatment beam noise will be held off and the movie will be paused.

If the patient reverts to treatment position within a pre-defined temporal threshold (1 minute), the simulated treatment will be resumed with a continuing movie.

If the patient cannot revert to the treatment position within a pre-defined time threshold/or the movement is beyond any pre-defined re-alignment threshold value the radiation beam and the movie will be turned off, the patient will be readjusted and the treatment will resume.

In any study case, the simulated PROMISE treatment will be ceased if therapists have to re-position the patient more than three times.

The simulated PROMISE treatment will be repeated in three times in three different days.

• Study Type: Interventional
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 10 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients Age: ≥4 and ≤10

Patients and his/her legal guardian must be willing and capable to provide informed consent to participate in the protocol.

Patients must be compliant to all required pretreatment evaluations:

1. Informed Consent
2. Medical Diagnosis
3. Demographics
4. Review subject eligibility criteria
5. Physical exam including vital signs, height and weight Vital signs (temperature, pulse, respirations, blood pressure) will be collected before simulation treatment.
6. Simulated PROMISE treatment screening Patient will be asked for lying on treatment couch for 30 seconds with PROMISE movie on. If patient stay still for 30 seconds, s/he is eligible for the simulated PROMISE treatment

Exclusion Criteria:

Patients aren't compliant to all required pretreatment evaluations

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Movie Induced Sedation Effect; Pediatric Radiation Oncology with Movie Induced Sedation Effect monitored by an AlignRT system (VisionRT LTD, UK).

Device: AlignRT system (VisionRT LTD, UK); Pediatric patient will watch age-proper movie during radiation treatment. The motion of pediatric patient will continually be monitored by an AlignRT system (VisionRT LTD, UK). Both movie and radiation beam will be paused if the motion of pediatric patient is beyond positioning accuracy threshold. Movie and beam will be resumed if pediatric patient is positioning with in tolerance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate the feasibility of applying PROMISE for pediatric radiotherapy by analyzing overall treatment time	Analyze overall treatment time including time for hardware and software setup	in three different days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine overall PROMISE radiotherapy treatment efficiency	- Analyze PROMISE workflow based on record time: Times of beam/movie pauses. Times the child reverts back to the treatment position.	in three different days
To quantify PROMISE radiotherapy treatment dose deviation	- Analyze the dose deviation from original treatment plan.	in three different days

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Steve Jiang, Ph.D, University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 27, 2018
• Primary Completion (ACTUAL): May 31, 2019
• Study Completion (ACTUAL): May 31, 2019

Study Registration Dates

• First Submitted: May 18, 2018
• First Submitted That Met QC Criteria: June 1, 2018
• First Posted (ACTUAL): June 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 25, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Non-sedated radiotherapy treatment
• Other Study ID Numbers: STU 042018-088

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No