Investigating the Use of Fluorescent Lectins to Identify Dysplasia and Cancer During Endoscopy and Surgery

Study Overview
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Brief Summary
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This is a feasibility study investigating the use of a fluorescently conjugated lectin to identify colorectal dysplasia and cancer during colonoscopy and surgery.

Official Title
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Investigating the Use of Fluorescent Lectins to Identify Dysplasia and Cancer During Endoscopy and Surgery

Conditions
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Colorectal Cancer, Colorectal Neoplasms, Colorectal Polyp

Intervention / Treatment
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* Drug: Fluorescent Lectin Application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study. Male or female, aged 18 years or above Participants undergoing endoscopic procedures including colonoscopy and flexible sigmoidoscopy or transanal endoscopic microsurgery (TEMS), including robotic assisted TEMS In the investigator's opinion, is able and willing to comply with all study requirements Exclusion Criteria Participant who is unable to unwilling to give informed consent Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. If there is an uncertainty regarding whether a woman could be pregnant, then they will be excluded from the study Participants with known egg allergies, ovalbumin allergy and soya allergies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluorescent Lectin Application<br>Fluorescein conjugated wisteria floribunda will be sprayed onto the colonic surface during colonoscopy or TEM surgery. | Drug: Fluorescent Lectin Application<br>* Fluorescein conjugated wisteria floribunda (a lectin).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signal to background ratios of identified colonic lesions under white light and under fluorescence | This outcome measure compares the fluorescence signal of lesions identified during colonoscopy. | During procedure | 
| Number of dysplastic and cancerous lesions identified under white light and under fluorescence | Number of lesions identified under white light colonoscopy will be compared to the number of lesions identified under fluorescence. | During procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of dysplastic and cancerous lesions identified under white light and fluorescence in different subgroups | Assessment of subgroups including ulcerative colitis, lesions suspicious of sessile serrated adenomas / traditional serrated adenomas | 12 months | 
| Resection margin of of lesions undergoing TEMS resection under white light and under fluorescence. | Planned resection margins will be compared under white light and under fluorescence. R0/R1 resection rates will be assessed post operatively. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Fluorescence guided surgery