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

NCT03070613 | Unknown Early Phase 1

• 1 other identifier: R37106
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Cancer; Colorectal Neoplasms; Colorectal Polyp

Keywords

Colonoscopy; Fluorescence guided surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Number of dysplastic and cancerous lesions identified under white light and fluorescence in different subgroups

  12 months

• Resection margin of of lesions undergoing TEMS resection under white light and under fluorescence.

  12 months

Study Arms (1)

Fluorescent Lectin Application

EXPERIMENTAL

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

Drug: Fluorescent Lectin Application

Interventions

Fluorescent Lectin Application DRUG

Fluorescein conjugated wisteria floribunda (a lectin).

Fluorescent Lectin Application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (2)

Thomas Barnes

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, OX3 9DS, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic Clinical Lecturer

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 3, 2017
• Study Start: April 23, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: July 18, 2017

Record last verified: 2017-07

Locations

GB (2)