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

University of Oxford

Status and phase: Unknown; Early Phase 1

Conditions: Colorectal Polyp; Colorectal Neoplasms; Colorectal Cancer

Treatments: Drug: Fluorescent Lectin Application

Study type: Interventional

Funder types: Other

Identifiers

NCT03070613

R37106

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Fluorescent Lectin Application

Experimental group

Description:

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

Treatment:

Drug: Fluorescent Lectin Application