Childhood CancerEarly Phase 1NCT03556930
Simulated Radiotherapy Treatment Assisted With Pediatric Radiation Oncology With Movie Induced Sedation Effect Technique
A Early Phase 1 study testing AlignRT system (VisionRT LTD, UK) in people with Childhood Cancer, run by University of Texas Southwestern Medical Center.
Trial 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). Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Childhood Cancer
- What is being tested?
- AlignRT system (VisionRT LTD, UK)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 27 Apr 2018to 31 May 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Patients aren't compliant to all required pretreatment evaluations
About this study
Official title: 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).
Read the 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.
- Conditions
- Childhood Cancer
- Being tested
- AlignRT system (VisionRT LTD, UK)
- Keywords
- Non-sedated radiotherapy treatment
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Movie Induced Sedation Effect | Experimental | Pediatric Radiation Oncology with Movie Induced Sedation Effect monitored by an AlignRT system (VisionRT LTD, UK). Receives: Device: AlignRT system (VisionRT LTD, UK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: in three different days
Secondary outcomes (2)
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.
Measured: in three different days
To quantify PROMISE radiotherapy treatment dose deviation
- Analyze the dose deviation from original treatment plan.
Measured: in three different days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start27 Apr 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Why it stopped: Project was never initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steve Jiang, Ph.D, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556930
- Sponsor's protocol ID
- STU 042018-088
- Status last verified
- Aug 2020
- First submitted
- 18 May 2018
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulated Radiotherapy Treatment Assisted With Pediatric Radiation Oncology With Movie Induced Sedation Effect (PROMISE) Technique
- ClinicalTrials.gov ID
- NCT03556930
- Acronym / sponsor ID
- STU 042018-088
- Conditions
- Childhood Cancer
- Keywords
- Non-sedated radiotherapy treatment
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Project was never initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 27 Apr 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 14 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Movie Induced Sedation Effect | Experimental | Device: AlignRT system (VisionRT LTD, UK)Pediatric Radiation Oncology with Movie Induced Sedation Effect monitored by an AlignRT system (VisionRT LTD, UK). |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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.
- Informed Consent
- Medical Diagnosis
- Demographics
Key exclusion criteria (1 listed)
- Patients aren't compliant to all required pretreatment evaluations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Movie Induced Sedation Effect |
Primary outcome
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
2 secondary outcomes
To determine overall PROMISE radiotherapy treatment efficiency
Time frame: in three different days
To quantify PROMISE radiotherapy treatment dose deviation
Time frame: in three different days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Jiang, Ph.D principal investigator
University of Texas Southwestern Medical Center
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing AlignRT system (VisionRT LTD, UK) in people with Childhood Cancer, run by University of Texas Southwestern Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the feasibility of applying PROMISE for pediatric radiotherapy by analyzing overall treatment time (time frame: in three different days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2020.