Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03556930
Recruitment Status : Withdrawn (Project was never initiated.)
First Posted : June 14, 2018
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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).

Condition or disease Intervention/treatment Phase
Childhood Cancer Device: AlignRT system (VisionRT LTD, UK) Early Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Simulated Radiotherapy Treatment Assisted With Pediatric Radiation Oncology With Movie Induced Sedation Effect (PROMISE) Technique
Actual Study Start Date : April 27, 2018
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019

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.




Primary Outcome Measures :
  1. To investigate the feasibility of applying PROMISE for pediatric radiotherapy by analyzing overall treatment time [ Time Frame: in three different days ]
    Analyze overall treatment time including time for hardware and software setup


Secondary Outcome Measures :
  1. To determine overall PROMISE radiotherapy treatment efficiency [ Time Frame: in three different days ]

    - Analyze PROMISE workflow based on record time:

    Times of beam/movie pauses. Times the child reverts back to the treatment position.


  2. To quantify PROMISE radiotherapy treatment dose deviation [ Time Frame: in three different days ]
    - Analyze the dose deviation from original treatment plan.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


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): NCT03556930


Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Steve Jiang, Ph.D University of Texas Southwestern Medical Center
Layout table for additonal information
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03556930    
Other Study ID Numbers: STU 042018-088
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Texas Southwestern Medical Center:
Non-sedated radiotherapy treatment