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

July 13, 2017 updated by: TREVOR MING-YEE YEUNG, University of Oxford
This is a feasibility study investigating the use of a fluorescently conjugated lectin to identify colorectal dysplasia and cancer during colonoscopy and surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DS
        • Oxford University Hospitals NHS Foundation Trust
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Thomas Barnes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Signal to background ratios of identified colonic lesions under white light and under fluorescence
Time Frame: During procedure
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
Time Frame: During procedure
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
Time Frame: 12 months
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.
Time Frame: 12 months
Planned resection margins will be compared under white light and under fluorescence. R0/R1 resection rates will be assessed post operatively.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 23, 2017

Primary Completion (ANTICIPATED)

March 1, 2018

Study Completion (ANTICIPATED)

March 1, 2018

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

February 27, 2017

First Posted (ACTUAL)

March 3, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2017

Last Update Submitted That Met QC Criteria

July 13, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R37106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

To be confirmed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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