Back to resultsInvestigating the Use of Fluorescent Lectins to Identify Dysplasia and Cancer During Endoscopy and Surgery
Primary Purpose
Colorectal Cancer, Colorectal Neoplasms, Colorectal Polyp
Status
Unknown status
Phase
Early Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Fluorescent Lectin Application
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Colonoscopy, Fluorescence guided surgery
Eligibility 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
Sites / Locations
- Thomas Barnes
- Oxford University Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fluorescent Lectin Application
Arm Description
Fluorescein conjugated wisteria floribunda will be sprayed onto the colonic surface during colonoscopy or TEM surgery.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Number of dysplastic and cancerous lesions identified under white light and fluorescence in different subgroups
Assessment of subgroups including ulcerative colitis, lesions suspicious of sessile serrated adenomas / traditional serrated adenomas
Resection margin of of lesions undergoing TEMS resection under white light and under fluorescence.
Planned resection margins will be compared under white light and under fluorescence. R0/R1 resection rates will be assessed post operatively.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03070613
Brief Title
Investigating the Use of Fluorescent Lectins to Identify Dysplasia and Cancer During Endoscopy and Surgery
Official Title
Investigating the Use of Fluorescent Lectins to Identify Dysplasia and Cancer During Endoscopy and Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 23, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Anticipated)
Study Completion Date
March 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oxford
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colorectal Neoplasms, Colorectal Polyp
Keywords
Colonoscopy, Fluorescence guided surgery
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fluorescent Lectin Application
Arm Type
Experimental
Arm Description
Fluorescein conjugated wisteria floribunda will be sprayed onto the colonic surface during colonoscopy or TEM surgery.
Intervention Type
Drug
Intervention Name(s)
Fluorescent Lectin Application
Intervention Description
Fluorescein conjugated wisteria floribunda (a lectin).
Primary Outcome Measure Information:
Title
Signal to background ratios of identified colonic lesions under white light and under fluorescence
Description
This outcome measure compares the fluorescence signal of lesions identified during colonoscopy.
Time Frame
During procedure
Title
Number of dysplastic and cancerous lesions identified under white light and under fluorescence
Description
Number of lesions identified under white light colonoscopy will be compared to the number of lesions identified under fluorescence.
Time Frame
During procedure
Secondary Outcome Measure Information:
Title
Number of dysplastic and cancerous lesions identified under white light and fluorescence in different subgroups
Description
Assessment of subgroups including ulcerative colitis, lesions suspicious of sessile serrated adenomas / traditional serrated adenomas
Time Frame
12 months
Title
Resection margin of of lesions undergoing TEMS resection under white light and under fluorescence.
Description
Planned resection margins will be compared under white light and under fluorescence. R0/R1 resection rates will be assessed post operatively.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Thomas Barnes
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation Trust
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DS
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
To be confirmed
Learn more about this trial
Investigating the Use of Fluorescent Lectins to Identify Dysplasia and Cancer During Endoscopy and Surgery
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