Investigating the use of a new fluorescent compound to identify pre cancerous and cancerous lesions in the bowel

Completed

• Conditions: Colorectal cancer; Cancer

• Registration Number: ISRCTN90128107
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-07
• Last Update Posted: 12 February 2018
• Study Completion: 2019-01-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Participant is willing and able to give informed consent for participation in the study
2. Male or female, aged 18 years or over
3. Patients undergoing endoscopic procedures including colonoscopy and flexible sigmoidoscopy as well as transanal endoscopic microsurgery (TEMS), including robotic assisted TEMS
4. In the investigator’s opinion, is able and willing to comply with all study requirements; 1. Participant is willing and able to give informed consent for participation in the study
2. Male or female, aged 18 years or over
3. Patients undergoing endoscopic procedures including colonoscopy and flexible sigmoidoscopy as well as transanal endoscopic microsurgery (TEMS), including robotic assisted TEMS
4. In the investigator’s opinion, is able and willing to comply with all study requirements

Exclusion Criteria

1. Patient who is unable or unwilling to give informed consent
2. Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. If there is an uncertainly regarding whether a woman could be pregnant, then they will be excluded from the study.
3. Patients with known egg allergies, ovalbumin allergy and soya allergies; 1. Patient who is unable or unwilling to give informed consent
2. Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. If there is an uncertainly regarding whether a woman could be pregnant, then they will be excluded from the study.
3. Patients with known egg allergies, ovalbumin allergy and soya allergies

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Signal to background ratio after application of lectin is measured using the fluorescence ratio of WFA binding to normal versus dysplastic/early cancer tissue during endoscopic or surgical procedure<br>2. Detection rate of dysplastic and cancerous lesions compared to white light alone is measured as the number of lesions identified during endoscopic or surgical procedure and calculating the sensitivity and specificity<br>;1. Signal to background ratio after application of lectin is measured using the fluorescence ratio of WFA binding to normal versus dysplastic/early cancer tissue during endoscopic or surgical procedure<br>2. Detection rate of dysplastic and cancerous lesions compared to white light alone is measured as the number of lesions identified during endoscopic or surgical procedure and calculating the sensitivity and specificity<br>

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures;No secondary outcome measures