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
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Colorectal Neoplasms Colorectal Polyp||Drug: Fluorescent Lectin Application||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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).
- 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.
- 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.
- 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
- 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.
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
|Oxford, Oxfordshire, United Kingdom, OX3 7LE|
|Oxford University Hospitals NHS Foundation Trust|
|Oxford, Oxfordshire, United Kingdom, OX3 9DS|