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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03070613
• Other study ID #: R37106
• Status: Enrolling by invitation
• Phase: Early Phase 1
• First received: February 22, 2017
• Last updated: July 13, 2017
• Start date: April 23, 2017
• Est. completion date: March 1, 2018

Study information

• Verified date: July 2017
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a feasibility study investigating the use of a fluorescently conjugated lectin to identify colorectal dysplasia and cancer during colonoscopy and surgery.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Colorectal Polyp

Intervention

Drug:
• Fluorescent Lectin Application
Fluorescein conjugated wisteria floribunda (a lectin).

Locations

Country	Name	City	State
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford	Oxfordshire
United Kingdom	Thomas Barnes	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	12 months
Secondary	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.	12 months