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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer; Colorectal Neoplasms; Colorectal Polyp	Drug: Fluorescent Lectin Application	Early Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	50 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	Investigating the Use of Fluorescent Lectins to Identify Dysplasia and Cancer During Endoscopy and Surgery
Actual Study Start Date :	April 23, 2017
Estimated Primary Completion Date :	March 1, 2018
Estimated Study Completion Date :	March 1, 2018

Arms and Interventions

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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).

Outcome Measures

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Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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
2. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

University of Oxford

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	TREVOR MING-YEE YEUNG, Academic Clinical Lecturer, University of Oxford
ClinicalTrials.gov Identifier:	NCT03070613 History of Changes
Other Study ID Numbers:	R37106
First Posted:	March 3, 2017
Last Update Posted:	July 18, 2017
Last Verified:	July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided
Plan Description:	To be confirmed

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by TREVOR MING-YEE YEUNG, University of Oxford:

Colonoscopy; Fluorescence guided surgery

Additional relevant MeSH terms:

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