Tissue Characterization With Hyperspectral Imaging (HSI)

NCT04230603 | Unknown

• 1 other identifier: 201905
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Tissue Perfusion; Tumor; Inflammation; Inflammatory Bowel Diseases

Keywords

hyperspectral imaging; tissue detection; tumor detection; infammatory bowel disease; colorectal cancer

Outcome Measures

Primary Outcomes (3)

• 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)

• Tissue recognition with HSI

  different tissues can be differentiated from each other with HSI

  after the operation within 24 hours

• Inflammatory classification with HSI

  Classification of the grade of the inflammation e.g. in IBD

  after the operation within 24 hours

Secondary Outcomes (1)

• Tissue perfusion

  direct during the Operation (ca. 10-15 Minutes)

Study Arms (1)

Hyperspectral imaging

EXPERIMENTAL

diagnostic hyperspectral imaging of the human tissue an correlation with local blood parameters and local pathological examination

Procedure: Hyperspectral imaging; Diagnostic Test: Lactate acid measurement; Diagnostic Test: pathological examination

Interventions

Hyperspectral imaging PROCEDURE

Photos were taken with the hyperspectral camera of the human tissue

Also known as: Marking of the target region (Suture/Clip/ink)

Hyperspectral imaging

Lactate acid measurement DIAGNOSTIC_TEST

At the marked regions of the specimen, a lactate acid measurement was performed.

Hyperspectral imaging

pathological examination DIAGNOSTIC_TEST

At the marked regions of the specimen, the pathological examination was performed.

Hyperspectral imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with surgical procedure

You may not qualify if:

• inability to consent

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (1)

Universitätsklinikum Leipzig - AöR

Leipzig, Saxony, 04103, Germany

RECRUITING

MeSH Terms

Conditions

Neoplasms; Inflammation; Inflammatory Bowel Diseases; Colorectal Neoplasms

Interventions

Hyperspectral Imaging

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Colonic Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Ines Gockel, MD, Prof.

  University of Leipzig

  STUDY DIRECTOR

Central Study Contacts

Boris Jansen-Winkeln, MD, PD

CONTACT

+49-314-97; boris.jansen-winkeln@medizin.uni-leipzig.de

Ines Gockel, MD, Prof.

CONTACT

+49-314-97; ines.gockel@medizin.uni-leipzig.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Boris Jansen-Winkeln

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 18, 2020
• Study Start: June 6, 2019
• Primary Completion: January 2, 2022
• Study Completion: June 2, 2022
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)