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

NCT03556930 | Withdrawn Early Phase 1 DMC

• 1 other identifier: STU 042018-088
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Childhood Cancer

Keywords

Non-sedated radiotherapy treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To determine overall PROMISE radiotherapy treatment efficiency

  in three different days

• To quantify PROMISE radiotherapy treatment dose deviation

  in three different days

Study Arms (1)

Movie Induced Sedation Effect

EXPERIMENTAL

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

Device: AlignRT system (VisionRT LTD, UK)

Interventions

AlignRT system (VisionRT LTD, UK) DEVICE

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.

Movie Induced Sedation Effect

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• Informed Consent
• Medical Diagnosis
• Demographics
• Review subject eligibility criteria
• Physical exam including vital signs, height and weight Vital signs (temperature, pulse, respirations, blood pressure) will be collected before simulation treatment.
• 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

You may not qualify if:

• Patients aren't compliant to all required pretreatment evaluations

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

MeSH Terms

Conditions

Neoplasms

Study Officials

• Steve Jiang, Ph.D

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 14, 2018
• Study Start: April 27, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: August 27, 2020

Record last verified: 2020-08