Tissue PerfusionHSITNCT04230603
Tissue Characterization With Hyperspectral Imaging (HSI)
A study testing Hyperspectral imaging, Lactate acid measurement and pathological examination in people with Tissue Perfusion and Tumor, run by University of Leipzig at 1 site in Germany.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tissue Perfusion, Tumor, Inflammation
- What is being tested?
- Hyperspectral imaging, Lactate acid measurement and pathological examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 6 Jun 2019to 2 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients with surgical procedure
Who cannot join
- inability to consent
Trial locations and contacts
1 site in 1 country.
Boris Jansen-Winkeln, MD, PD contact
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Leipzig - AöR
Leipzig, Saxony, 04103
Boris Jansen-Winkeln, MD, PD, +49-341-97- ext. 17200, boris.jansen-winkeln@medizin.uni-leipzig.de
Ines Gockel, MD, Prof., +49-341-97- ext. 17200, ines.gockel@medizin.uni-leipzig.de
About this study
Official title: Tissue Characterisation With Hyperspectral Imaging Methods
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
Read the 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.
- Conditions
- Tissue Perfusion, Tumor, Inflammation, Inflammatory Bowel Diseases
- Being tested
- Hyperspectral imaging, Lactate acid measurement, pathological examination
- Keywords
- hyperspectral imaging, tissue detection, tumor detection, infammatory bowel disease, colorectal cancer
- Medical subject headings
- Neoplasms, Inflammation, Inflammatory Bowel Diseases, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperspectral imagingProcedure or surgery
Also called Marking of the target region (Suture/Clip/ink)
Photos were taken with the hyperspectral camera of the human tissue
Lactate acid measurementDiagnostic test
At the marked regions of the specimen, a lactate acid measurement was performed.
pathological examinationDiagnostic test
At the marked regions of the specimen, the pathological examination was performed.
| Study group | Role | What they receive |
|---|---|---|
| Hyperspectral imaging | Experimental | diagnostic hyperspectral imaging of the human tissue an correlation with local blood parameters and local pathological examination Receives: Procedure: Hyperspectral imaging; Diagnostic Test: Lactate acid measurement; Diagnostic Test: pathological examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor detection with HSI
Due to the non-invasive diagnostics with the HSI camera, tumor tissue can be distinguished from healthy tissue.
Measured: direct during the Operation (ca. 15-20 Minutes)
Tissue recognition with HSI
different tissues can be differentiated from each other with HSI
Measured: after the operation within 24 hours
Inflammatory classification with HSI
Classification of the grade of the inflammation e.g. in IBD
Measured: after the operation within 24 hours
Secondary outcomes (1)
Tissue perfusion
Tissue perfusion in the upper and lower tissue layers measured with the HSI Camera
Measured: direct during the Operation (ca. 10-15 Minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start6 Jun 2019
- Primary completion2 Jan 2022 (estimated)
- Study completion2 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue PerfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Boris Jansen-Winkeln, University of Leipzig
- Investigators
- Ines Gockel, MD, Prof., Study director, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230603
- Sponsor's protocol ID
- 201905
- Acronym
- HSIT
- Status last verified
- Sep 2020
- First submitted
- 13 Jan 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no sharing
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Characterisation With Hyperspectral Imaging Methods
- ClinicalTrials.gov ID
- NCT04230603
- Acronym / sponsor ID
- HSIT / 201905
- Conditions
- Tissue Perfusion, Tumor, Inflammation, Inflammatory Bowel Diseases
- Keywords
- hyperspectral imaging, tissue detection, tumor detection, infammatory bowel disease, colorectal cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 2 Jan 2022 (estimated)
- Study completion
- 2 Jun 2022 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperspectral imaging | Experimental | Procedure: Hyperspectral imaging, Diagnostic Test: Lactate acid measurement, Diagnostic Test: pathological examinationdiagnostic hyperspectral imaging of the human tissue an correlation with local blood parameters and local pathological examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with surgical procedure
Key exclusion criteria (1 listed)
- inability to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperspectral imagingAlso: Marking of the target region (Suture/Clip/ink)Photos were taken with the hyperspectral camera of the human tissue | Procedure or surgery | Hyperspectral imaging |
| Lactate acid measurementAt the marked regions of the specimen, a lactate acid measurement was performed. | Diagnostic test | Hyperspectral imaging |
| pathological examinationAt the marked regions of the specimen, the pathological examination was performed. | Diagnostic test | Hyperspectral imaging |
Primary outcome
Tumor detection with HSI
Time frame: 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.
Tissue recognition with HSI
Time frame: after the operation within 24 hours
different tissues can be differentiated from each other with HSI
Inflammatory classification with HSI
Time frame: after the operation within 24 hours
Classification of the grade of the inflammation e.g. in IBD
1 secondary outcome
Tissue perfusion
Time frame: direct during the Operation (ca. 10-15 Minutes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: No. no sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris Jansen-Winkeln, MD, PD contact
Ines Gockel, MD, Prof. study director
University of Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperspectral imaging, Lactate acid measurement and pathological examination in people with Tissue Perfusion and Tumor, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Boris Jansen-Winkeln, MD, PD (+49-314-97 ext. 17200, boris.jansen-winkeln@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor detection with HSI (time frame: direct during the Operation (ca. 15-20 Minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.