NCT05853549

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 18, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
Last Updated

May 10, 2023

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

May 2, 2023

Last Update Submit

May 2, 2023

Conditions

Vulvar Cancer

Keywords

Vulvar cancerSetup errorIntensity-modulated radiation therapyOptical surface monitoring system

Outcome Measures

Primary Outcomes (2)

  • The absolute values of setup error

    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.

    Through study completion, total an average of eight month

  • The distribution of setup error

    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 distribution of the standard laser-based setup and OSMS in the above six directions were compared.

    Through study completion, total an average of eight month

Study Arms (1)

optical surface monitoring system group

EXPERIMENTAL

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.

Device: optical surface monitoring system

Interventions

optical surface monitoring systemDEVICE

An optical surface monitoring system (OSMS) could achieve continuous monitoring of patient position through a nonradiographic and noninvasive technology, which has been widely applied to many sites of radiation therapy, including breast, intracranial, head and neck, abdomen, and extremities

optical surface monitoring system group

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must be informed of the investigational nature of this study and give written informed consent before treatment.
  • Age ≥18 years and ≤ 85 years.
  • Patients with histologically confirmed vulvar cancer.
  • No evidence of distant metastasis on CT, MRI or positron emission tomograph (PET)/CT.
  • No contraindications to CT scanning.
  • Indications for radiotherapy for vulvar cancer.
  • Adequate marrow: neutrophile granulocyte count ≥1.5\*10\^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100\*10\^9/L.
  • Normal liver and kidney function: Creatinine (Cr) \< 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 2\*upper limit of normal (ULN).

You may not qualify if:

  • No pathological diagnosis.
  • Remote metastasis.
  • Anticipated intolerance of pelvic radiotherapy.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

  • Hoisak 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: 29933878BACKGROUND

MeSH Terms

Conditions

Vulvar Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsVulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Fuquan Zhang, M.D.

    Peking Union Medical College Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2023

First Posted

May 10, 2023

Study Start

March 18, 2022

Primary Completion

September 30, 2022

Study Completion

March 15, 2023

Last Updated

May 10, 2023

Record last verified: 2022-03

Locations

CN(1)