- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03139942
Optical Polyp Testing for In Vivo Classification (OPTIC)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Polyps detected during a colonoscopy may range from benign to precancerous and cancerous. While experienced endoscopists can reliably recognise cancer, the difference between small polyps that have the potential to develop into cancer (adenomas) and those that do not (hyperplastic), is often ambiguous. The standard approach is to simply remove all polyps and analyse them in the histology lab. This means that many patients with hyperplastic polyps (40% of those detected) are unnecessarily exposed to risk of injury (bowel perforation and bleeding) during removal. Furthermore the NHS faces the significant cost of diagnosing this harmless colon tissue. If clinicians were able to accurately determine polyp type during endoscopy, without removal, then hyperplastic tissue could be left alone while potentially harmful tissue is removed.
A pilot study of a new endoscopic optical imaging probe (OPTIC), which analyses how different colours of light interact with tissue, is proposed. Previous research has indicated that these properties differ in hyperplastic and adenomatous polyps. The probe is contained within a normal endoscope and uses white light and blue/violet laser light to illuminate the tissue. The reflected and fluorescent light emitted, along with normal colour pictures of the polyp surface, are measured and recorded to quantify specific characteristics of each type.
Patients attending endoscopy clinics at Imperial College Healthcare NHS Trust will be asked to allow the use of the OPTIC probe during their colonoscopy. If the clinician detects a polyp that he/she intends to remove then this will be analysed using OPTIC before removal. The histology results from the tissue sample will be recorded and correlated to the OPTIC probe measurements. The resulting library of optical data will be used to design software to automatically categorise unknown polyps based on the OPTIC signal. The accuracy of the technique will be compared to the clinicians' visual assessments. The patients' involvement in the study ceases after the colonoscopy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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London, United Kingdom, SW7 2AZ
- Imperial College London
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients attending for screening colonoscopy, urgent colonoscopy for altered bowel habit (on a two week wait) or those patients attending for polyp surveillance or therapy.
Exclusion Criteria:
- Patients with colitis, familial adenomatous polyposis or those that have undergone previous surgery as these different pathologies may confound interpretation of the optical signals.
- At the discretion of the endoscopist patients with poor bowel preparation will be excluded if it is judged that the colonoscopy cannot be completed. Further quality measures will be determined for reliable data acquisition (see outcome measures).
- Patients with acute gastrointestinal bleeding
- Patients with chronic liver disease
- Patients with abnormal coagulation or any other contra-indication to use of standard biopsy in routine diagnostic endoscopic procedures
- Patients who are unable or unwilling to give informed consent
- Patients under the age of 18 years
- Patients unable to speak English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Imaging using OPTIC probe
Single arm study to test the feasibility of a new device - the OPTIC imaging probe.
All participants enrolled in the study may be imaged using optical spectral reflectance and autofluorescence imaging during their endoscopy procedure.
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When a suitable area of tissue is identified by the clinician during a patient's colonoscopy (e.g., a polyp), the imaging probe is inserted into the colonoscope so that it can view the tissue.
Optical spectral reflectance and autofluorescence imaging is then performed to collect white light reflected by, and fluorescent light emitted from, the tissue.
This is then analysed by hardware and software components in the external analysis unit.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic accuracy of hyperplastic vs adenoma classification
Time Frame: 1-2 weeks (from day of endoscopy and optical measurement, to return of histology results for any detected polyp)
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Correlation of optical signals from colonic polyps and their histologically-confirmed diagnosis.
Quantification of sensitivity, specificity, negative predictive value.
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1-2 weeks (from day of endoscopy and optical measurement, to return of histology results for any detected polyp)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Extension of classification algorithm to other polyp types (higher grade adenomas and cancer)
Time Frame: 1-2 weeks (from day of endoscopy and optical measurement, to return of histology results for any detected polyp)
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Sensitivity and specificity of measured optical signals in differentiating different grades of adenoma.
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1-2 weeks (from day of endoscopy and optical measurement, to return of histology results for any detected polyp)
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Bowel preparation quality
Time Frame: 1 day (has bowel preparation been sufficient on day of endoscopy and optical measurement)
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Is bowel preparation quality sufficient for endoscopy to proceed?
Bowel preparation for some patients may be imperfect and hamper collection of optical data.
A measure of the quality and hence, reliability, of the measured data must be obtained for future reference in order to prevent erroneous readings.
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1 day (has bowel preparation been sufficient on day of endoscopy and optical measurement)
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Mean time added to endoscopy due to additional imaging
Time Frame: 1 day
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An estimate of the time added to an endoscopic examination of the colon due to the need to insert and remove the OPTIC probe
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1 day
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julian P Teare, MD FRCP, Imperial College London
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Pathological Conditions, Anatomical
- Intestinal Neoplasms
- Colorectal Neoplasms
- Intestinal Polyps
- Adenoma
- Polyps
- Colonic Polyps
- Colonic Neoplasms
- Colonic Diseases
Other Study ID Numbers
- IRAS186652
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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