Optical Polyp Testing for In Vivo Classification

NCT03139942 | Completed

• 1 other identifier: IRAS186652
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colonic Polyp; Colonic Diseases; Colonic Neoplasms; Colonic Adenoma; Colonic Adenocarcinoma; Colonic Dysplasia; Colonic Carcinoma; Colonic Cancer; Colon Hyperplastic Polyp

Keywords

Endoscopy; Colonoscopy; Hyperspectral imaging; Tissue classification; Tissue autofluorescence; Advanced imaging techniques

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Extension of classification algorithm to other polyp types (higher grade adenomas and cancer)

  1-2 weeks (from day of endoscopy and optical measurement, to return of histology results for any detected polyp)

• Bowel preparation quality

  1 day (has bowel preparation been sufficient on day of endoscopy and optical measurement)

• Mean time added to endoscopy due to additional imaging

  1 day

Study Arms (1)

Imaging using OPTIC probe

EXPERIMENTAL

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.

Device: Optical spectral reflectance and autofluorescence imaging

Interventions

Optical spectral reflectance and autofluorescence imaging DEVICE

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.

Imaging using OPTIC probe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London

London, SW7 2AZ, United Kingdom

Location

MeSH Terms

Conditions

Colonic Polyps; Colonic Diseases; Colonic Neoplasms

Interventions

Optical Imaging

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Julian P Teare, MD FRCP

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: May 4, 2017
• Study Start: March 14, 2017
• Primary Completion: July 11, 2017
• Study Completion: July 11, 2017
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

GB (1)