Tissue Characterization With Hyperspectral Imaging (HSI)

Inflammation Clinical Trial

— HSIT  

Official title:

Tissue Characterisation With Hyperspectral Imaging Methods

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04230603
• Other study ID #: 201905
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2019
• Est. completion date: June 2, 2022

Study information

• Verified date: September 2020
• Source: University of Leipzig
• Contact: Boris Jansen-Winkeln, MD, PD
• Phone: +49-314-97
• Email: boris.jansen-winkeln[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hyperspectral Imaging (HSI) is a contact free method to analyse the from the tissue reflected light in the range of 500-1000nm. Aim of the study is to identify special reflex patterns to identify special tissue

Description:

This HSI-camera provides hyperspectral images with a high spectral resolution (5 nm) in the visible and near infrared range (500-1000 nm). A RGB image and 4 false color images that represent physiologic parameters are intraoperatively provided by an analysis software. But after the procedure all spectral datasets could be investigated. To analyse and differentiate the different tissues, a catalog database is needed of all tissues including Tumors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 2, 2022
• Est. primary completion date: January 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients with surgical procedure

Exclusion Criteria:

• inability to consent

Related Conditions & MeSH terms

• Inflammation
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Tissue Perfusion
• Tumor

Intervention

Procedure:
• Hyperspectral imaging
Photos were taken with the hyperspectral camera of the human tissue

Diagnostic Test:
• Lactate acid measurement
At the marked regions of the specimen, a lactate acid measurement was performed.
• pathological examination
At the marked regions of the specimen, the pathological examination was performed.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Leipzig - AöR	Leipzig	Sachsen

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor detection with HSI	Due to the non-invasive diagnostics with the HSI camera, tumor tissue can be distinguished from healthy tissue.	direct during the Operation (ca. 15-20 Minutes)
Primary	Tissue recognition with HSI	different tissues can be differentiated from each other with HSI	after the operation within 24 hours
Primary	Inflammatory classification with HSI	Classification of the grade of the inflammation e.g. in IBD	after the operation within 24 hours
Secondary	Tissue perfusion	Tissue perfusion in the upper and lower tissue layers measured with the HSI Camera	direct during the Operation (ca. 10-15 Minutes)