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

Early Phase 1

• Conditions: Colorectal Neoplasms; Colorectal Cancer; Colorectal Polyp
• Interventions: Drug: Fluorescent Lectin Application

• Registration Number: NCT03070613
• Lead Sponsor: University of Oxford

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-02-22
• Study First Submitted QC: 2017-02-27
• Study First Posted: 2017-03-03
• Study Start: 2017-04-23
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-13
• Last Update Posted: 2017-07-18
• Primary Completion: 2018-03-01
• Study Completion: 2018-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fluorescent Lectin Application	Fluorescent Lectin Application	Fluorescein conjugated wisteria floribunda will be sprayed onto the colonic surface during colonoscopy or TEM surgery.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Thomas Barnes; 🇬🇧 Oxford, Oxfordshire, United Kingdom

Oxford University Hospitals NHS Foundation Trust; 🇬🇧 Oxford, Oxfordshire, United Kingdom