A prospective, multi-centered, assessor-blinded clinical pilot study to evaluate the sensitivity and specificity of the proposed cell/tissue histopathology image processor cCeLL – Ex vivo (Confocal Fluorescence Endomicroscopy) for intraoperative brain tumor diagnosis.
Not Applicable
Completed
- Conditions
- Neoplasms
- Registration Number
- KCT0008869
- Lead Sponsor
- Korea University Anam Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
1)Male or female patients >19 years of age;
2)Patient is suspected to have a brain tumor and has been scheduled for neurosurgery with a potential tumor resection;
3)Patient is willing and able to provide informed consent and understand its content.
Exclusion Criteria
1)Patients has undergone several surgeries on the lesion of interest.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the agreement between cCeLL Ex vivo and frozen section, the sensitivity of cCeLL ex vivo and frozen section, and the specificity of cCeLL ex vivo and frozen section. These endpoints will be assessed by a single pathologist in the analysis of tumor tissue.
- Secondary Outcome Measures
Name Time Method Comparison of time taken in tissue scanning, visualization, and interpretation using cCeLL – Ex vivo to time taken in frozen section analysis.;Required image counts for adequate analysis and diagnosis using cCeLL – Ex vivo;Number of non-diagnostic Image