Clinical trial · Interventional
Clinical Implementation of Surface-guided Radiation Therapy in Vulvar Cancer
A Prospective Study to Evaluated the Clinical Implementation Value of an Optical Surface Monitoring System in the Radiotherapy Setup for Patients With Vulvar Cancer, Compared to Standard Laser-based Setup
NCT05853549CI-TRIAL-00066339completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective study evaluated the clinical implementation value of an optical surface monitoring system (OSMS) in the radiotherapy setup for patients with vulvar cancer, compared to standard laser-based setup
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 |
|---|---|---|---|
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| optical surface monitoring system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- optical surface monitoring system group
- description
- Every radiotherapy fraction from each patients with OSMS technology. Marks were placed on each patient's skin to align the room lasers for presetup, and the setup was completed with information from the OSMS. The deviation values of setup were obtained. The absolute values of setup error and error distribution of the standard laser-based setup and OSMS in the multi-directions were compared.
- interventionNames
- Device: optical surface monitoring system
Primary outcomes (2)
- measure
- The absolute values of setup error
- timeFrame
- Through study completion, total an average of eight month
- description
- Marks were placed on each patient's skin to align the room lasers for presetup, and the setup was completed with information from the OSMS. The deviation values in multi-directions were obtained. The absolute values of setup error of the standard laser-based setup and OSMS in the above six directions were compared.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must be informed of the investigational nature of this study and give written informed consent before treatment. 2. Age ≥18 years and ≤ 85 years. 3. Patients with histologically confirmed vulvar cancer. 4. No evidence of distant metastasis on CT, MRI or positron emission tomograph (PET)/CT. 5. No contraindications to CT scanning. 6. Indications for radiotherapy for vulvar cancer. 7. Adequate marrow: neutrophile granulocyte count ≥1.5\*10\^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100\*10\^9/L. 8. Normal liver and kidney function: Creatinine (Cr) \< 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 2\*upper limit of normal (ULN). Exclusion Criteria: 1. No pathological diagnosis. 2. Remote metastasis. 3. Anticipated intolerance of pelvic radiotherapy. 4. Any severe disease which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control, and emotional disturbance.
References
Publications (1)
- BACKGROUNDHoisak JDP, Pawlicki T. The Role of Optical Surface Imaging Systems in Radiation Therapy. Semin Radiat Oncol. 2018 Jun;28(3):185-193. doi: 10.1016/j.semradonc.2018.02.003. PMID 29933878