Tissue Characterization With Hyperspectral Imaging (HSI)

Not Applicable

• Conditions: Tumor; Inflammatory Bowel Diseases; Inflammation; Tissue Perfusion
• Interventions: Procedure: Hyperspectral imaging; Diagnostic Test: Lactate acid measurement; Diagnostic Test: pathological examination

• Registration Number: NCT04230603
• Lead Sponsor: University of Leipzig

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2019-06-06
• Study First Submitted: 2020-01-13
• Study First Submitted QC: 2020-01-13
• Study First Posted: 2020-01-18
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-10
• Last Update Posted: 2020-09-16
• Primary Completion: 2022-01-02
• Study Completion: 2022-06-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• All patients with surgical procedure

Exclusion Criteria

• inability to consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hyperspectral imaging	Hyperspectral imaging	diagnostic hyperspectral imaging of the human tissue an correlation with local blood parameters and local pathological examination
Hyperspectral imaging	Lactate acid measurement	diagnostic hyperspectral imaging of the human tissue an correlation with local blood parameters and local pathological examination
Hyperspectral imaging	pathological examination	diagnostic hyperspectral imaging of the human tissue an correlation with local blood parameters and local pathological examination

Primary Outcome Measures

Name	Time	Method
Tissue recognition with HSI	after the operation within 24 hours	different tissues can be differentiated from each other with HSI
Inflammatory classification with HSI	after the operation within 24 hours	Classification of the grade of the inflammation e.g. in IBD
Tumor detection with HSI	direct during the Operation (ca. 15-20 Minutes)	Due to the non-invasive diagnostics with the HSI camera, tumor tissue can be distinguished from healthy tissue.

Secondary Outcome Measures

Name	Time	Method
Tissue perfusion	direct during the Operation (ca. 10-15 Minutes)	Tissue perfusion in the upper and lower tissue layers measured with the HSI Camera

Trial Locations

Locations (1)

Universitätsklinikum Leipzig - AöR; 🇩🇪 Leipzig, Sachsen, Germany