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

NCT ID: NCT03070613

Last Updated: 2017-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-23

Study Completion Date

2018-03-01

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.

Detailed Description

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Conditions

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Colorectal Cancer Colorectal Neoplasms Colorectal Polyp

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Fluorescent Lectin Application

Fluorescein conjugated wisteria floribunda will be sprayed onto the colonic surface during colonoscopy or TEM surgery.

Group Type EXPERIMENTAL

Fluorescent Lectin Application

Intervention Type DRUG

Fluorescein conjugated wisteria floribunda (a lectin).

Interventions

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Fluorescent Lectin Application

Fluorescein conjugated wisteria floribunda (a lectin).

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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TREVOR MING-YEE YEUNG

Academic Clinical Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Thomas Barnes

Oxford, Oxfordshire, United Kingdom

Site Status

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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R37106

Identifier Type: -

Identifier Source: org_study_id

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