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

Intraoperative analysis of tumor tissue using stimulated Raman histology and the NIO Laser Imaging System. - Intraop_SRH_21

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00028184

Enrollment

15000

Registered

2022-03-11

Start date

2021-08-18

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C71 C72 C70 D32 D33 D42 D43

Interventions

Group 1: intraoperative rapid section diagnostics by Raman microscopy

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Secondary goal is AI-based differentiation of tumor tissue, infiltration zone and healthy tissue with consideration of 5-ALA and/or ICG fluorescence. Furthermore, the usability and integration possibilities of the NIO Laser Imaging System will be reviewed and analyzed. 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.	—

Measure

Time frame

Secondary goal is AI-based differentiation of tumor tissue, infiltration zone and healthy tissue with consideration of 5-ALA and/or ICG fluorescence. Furthermore, the usability and integration possibilities of the NIO Laser Imaging System will be reviewed and analyzed. 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.

—

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026