Colonic Neoplasms Clinical Trial
— OPTICOfficial title:
Optical Polyp Testing for In Vivo Classification
NCT number | NCT03139942 |
Other study ID # | IRAS186652 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 14, 2017 |
Est. completion date | July 11, 2017 |
Verified date | April 2019 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Small growths detected in the colon (polyps) during a colonoscopy may or may not have the potential to develop into cancer. However, since visual inspection alone cannot separate all potentially harmful polyps from harmless ones, the standard approach is to remove them all for histological lab examination, exposing patients to risk of injury and putting a significant demand on hospital resources. An accurate method of determining polyp type during endoscopy would enable the clinician to only remove potentially harmful polyps. A new endoscopic optical imaging probe (OPTIC), which analyses how light interacts with tissue, is proposed to do this. 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. Optical measurements of polyps detected in endoscopy clinics at Imperial College Healthcare NHS Trust will be analysed to determine if the signal can be used to differentiate different polyp types.
Status | Completed |
Enrollment | 13 |
Est. completion date | July 11, 2017 |
Est. primary completion date | July 11, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Imperial College London | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic accuracy of hyperplastic vs adenoma classification | Correlation of optical signals from colonic polyps and their histologically-confirmed diagnosis. Quantification of sensitivity, specificity, negative predictive value. | 1-2 weeks (from day of endoscopy and optical measurement, to return of histology results for any detected polyp) | |
Secondary | Extension of classification algorithm to other polyp types (higher grade adenomas and cancer) | Sensitivity and specificity of measured optical signals in differentiating different grades of adenoma. | 1-2 weeks (from day of endoscopy and optical measurement, to return of histology results for any detected polyp) | |
Secondary | Bowel preparation quality | 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. | 1 day (has bowel preparation been sufficient on day of endoscopy and optical measurement) | |
Secondary | Mean time added to endoscopy due to additional imaging | An estimate of the time added to an endoscopic examination of the colon due to the need to insert and remove the OPTIC probe | 1 day |
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