Intraoperative analysis of tumor tissue using stimulated Raman histology and the NIO Laser Imaging System.

Recruiting

Conditions: C72
D43
C71
D42
C70
D32
Malignant neoplasm of spinal cord, cranial nerves and other parts of central nervous system
D33
Benign neoplasm of meninges
Malignant neoplasm of brain

Registration Number: DRKS00028184

Lead Sponsor: Klinik für Allgemeine Neurochirurgie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

1. the patient(s) is (are) of legal age
2. the patient is capable of giving consent
3. the patient(s) is (are) undergoing tumor surgery at the neuro-oncology center of the University Hospital Cologne independently of the study.
4. the patient agrees to participate in the above mentioned study.

Exclusion Criteria

1. lack of consent to participate in the study
2. legal incapacity

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome is to test the validity and reliability of acquired SRH images by human neuropathological, and in parallel AI-based analysis and diagnosis compared to conventional neuropathological examination.

Secondary Outcome Measures

Name	Time	Method
Secondary goal is AI-based differentiation of tumor tissue, infiltration zone and healthy tissue with consideration of 5-ALA and/or ICG fluorescence.<br>Furthermore, the usability and integration possibilities of the NIO Laser Imaging System will be reviewed and analyzed.<br>The long-term goal of the study is to reduce the currently high waiting time of a frozen section and its diagnosis (45-90 minutes, depending on transport time, among other things) to a few minutes. Since the automatic analysis would not be bound to opening hours of the pathological institute, the possibility of a frozen section would also be available at night. In addition, we postulate that the low-threshold detection of 5-ALA or ICG via the NIO system would allow a better delineation of the infiltration zone from healthy tissue, thus further improving the current microscope-based resection and the immediate intraoperative diagnostics could thus have a positive impact on a rapid follow-up of the postoperative treatment options.