Investigating the Use of Fluorescent Lectins to Identify Dysplasia and Cancer During Endoscopy and Surgery
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| ClinicalTrials.gov Identifier: NCT03070613 |
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Recruitment Status :
Enrolling by invitation
First Posted : March 3, 2017
Last Update Posted : July 18, 2017
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Sponsor:
University of Oxford
Information provided by (Responsible Party):
TREVOR MING-YEE YEUNG, University of Oxford
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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.
| 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) |
| Primary Purpose: | Diagnostic |
| 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 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Fluorescent Lectin Application
Fluorescein conjugated wisteria floribunda will be sprayed onto the colonic surface during colonoscopy or TEM surgery.
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Drug: Fluorescent Lectin Application
Fluorescein conjugated wisteria floribunda (a lectin). |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
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
Locations
| United Kingdom | |
| Thomas Barnes | |
| Oxford, Oxfordshire, United Kingdom, OX3 7LE | |
| Oxford University Hospitals NHS Foundation Trust | |
| Oxford, Oxfordshire, United Kingdom, OX3 9DS | |
Sponsors and Collaborators
University of Oxford
| Responsible Party: | TREVOR MING-YEE YEUNG, Academic Clinical Lecturer, University of Oxford |
| ClinicalTrials.gov Identifier: | NCT03070613 History of Changes |
| Other Study ID Numbers: |
R37106 |
| First Posted: | March 3, 2017 Key Record Dates |
| Last Update Posted: | July 18, 2017 |
| Last Verified: | July 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | To be confirmed |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by TREVOR MING-YEE YEUNG, University of Oxford:
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Colonoscopy Fluorescence guided surgery |
Additional relevant MeSH terms:
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Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |