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

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ClinicalTrials.gov Identifier: NCT03070613
Recruitment Status : Enrolling by invitation
First Posted : March 3, 2017
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
TREVOR MING-YEE YEUNG, University of Oxford

Study Description
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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

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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, Older Adult)
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070613


Locations
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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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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    Key Record Dates
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

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