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

Early Phase 1UnknownNCT03070613

University of Oxford50 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Colorectal Cancer Colorectal Neoplasms Colorectal Polyp

Interventions

Fluorescent Lectin ApplicationDRUG

Fluorescein conjugated wisteria floribunda (a lectin).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Thomas Barnes

Oxford, Oxfordshire, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: During procedure

Secondary Outcomes

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

Time frame: 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.

Time frame: 12 months

Data from ClinicalTrials.gov

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