Clinical trial · Interventional
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
NCT03556930CI-TRIAL-00046829withdrawnEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Project was never initiated.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AlignRT system (VisionRT LTD, UK) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Movie Induced Sedation Effect
- description
- Pediatric Radiation Oncology with Movie Induced Sedation Effect monitored by an AlignRT system (VisionRT LTD, UK).
- interventionNames
- Device: AlignRT system (VisionRT LTD, UK)
Primary outcomes (1)
- measure
- To investigate the feasibility of applying PROMISE for pediatric radiotherapy by analyzing overall treatment time
- timeFrame
- in three different days
- description
- Analyze overall treatment time including time for hardware and software setup
Secondary outcomes (2)
- measure
- To determine overall PROMISE radiotherapy treatment efficiency
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 10 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.