Symptoms and General Pathology

All Conditions

Colonic Polyps

Polyps

Hyperplasia

Pathological Conditions, Anatomical

Intestinal Polyps

Anti-Infective Agents

All Drugs and Chemicals

Herbal and Botanical

Proflavine

Anti-Infective Agents, Local

Cola

3-ml of 0.01% proflavine(derived from dissolving 10 mg proflavine hemisulfate USP in 100 ml sterile water)

Proflavine Hemisulfate

Sharmila Anandasabapathy, MD

The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the colon can assist clinicians in detecting dysplastic (precancerous) and neoplastic areas. This is a pilot study of a novel technology, a miniaturized microscope device which can be used during standard endoscopy to image the gastrointestinal epithelium. Theoretically, by visualizing superficial mucosal changes at a high-resolution and magnification, the investigators will be able to obtain optical images that can be used to guide endoscopic biopsy and polypectomy. This may foster the selective targeting of dysplasia/neoplasia, thereby improving diagnostic accuracy.

Evaluation of a Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia

Evaluation of Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia

Anandasabapathy, Sharmila, M.D.

Digestive System Diseases

Neoplasms

Colonic Diseases

Carcinoma

Colonic Neoplasms

Adenocarcinoma

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

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.

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.

Optical spectral reflectance and autofluorescence imaging

Julian P Teare, MD FRCP

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.

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.

Optical Polyp Testing for In Vivo Classification

Only anonymised data will be shared. The research team may share findings from the study with non-Imperial College academic collaborators, who will further develop aspects of its imaging capabilities.

Correlation of optical signals from colonic polyps and their histologically-confirmed diagnosis. Quantification of sensitivity, specificity, negative predictive value.

Sensitivity and specificity of measured optical signals in differentiating different grades of adenoma.

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.

An estimate of the time added to an endoscopic examination of the colon due to the need to insert and remove the OPTIC probe

Imperial College London

Irritable Bowel Syndrome

Adenomatous Polyps

Syndrome

Colonic Diseases, Functional

The study subjects will be high-risk for colonic adenomas (i.e. strong family history of adenomas/adenocarcinoma or personal history of adenomas/adenocarcinoma), known adenoma scheduled for endoscopic resection, or in subjects with suspected dysplasia in inflammatory bowel disease (IBD). Fluorescein will be sprayed on the area of interest to provide imaging contrast for the images taken with the confocal endomicroscope.

This instrument provides real-time endoscopic "histology" to guide endoscopic biopsy or endoscopic mucosal resection (EMR) in the patient study group during colonoscopies.

confocal endomicroscope

Fluorescent dye used for imaging contrast only.

Fluorescein

Danielle Kim Turgeon, MD

The overall aim of this research project is to evaluate the imaging performance of a confocal endomicroscope. Fluorescein, an FDA-approved topical fluorescent dye, will be used to provide topical mucosal contrast. The purpose of this instrument is to provide real-time endoscopic "histology" to guide endoscopic biopsy or endoscopic mucosal resection (EMR) in the patient study group. This endomicroscope probe will be used during colonoscopies in subjects with colonic dysplasia, known colonic adenomatous polyps scheduled for endoscopic resection, or suspected dysplasia in subjects with Inflammatory Bowel Disease (IBD).

The device is being tested in small groups of individuals: generally less than 10 for each of a variety of histologically different colonic lesions or diseases (eg. IBD, adenomas, sessile seriated adenomas (SSAs), hyperplastic polyps, normal tissue).

Study of Performance of Confocal Endomicroscope With Fluorescein Imaging Agent in the Colon

The test product efficacy will be assessed by evaluating the fluorescence intensities measured from suspicious regions of colonic mucosa where the agent is administered compared to adjacent normal mucosa.

University of Michigan

Professor of Internal Medicine and Clinical Track Faculty Ombuds, Medical School

During colonoscopy, the Clinician inspect for the presence of polyps as per routine clinical practice with the CAD EYE function turned off. When a polyp is encountered, the Clinician will make a prediction on the histology based on the white light and BLI features of the polyp with and without optical magnification, as per routine clinical practice. Following this, the CAD EYE function will be switched on and the Clinician will take note of the CADx prediction for the same polyp, which will be either "neoplastic" or "hyperplastic".

In addition, other polyp features such as the size and location will be recorded, which is similar to what is performed in routine clinical practice. The polyp will be resected and sent for pathological examination, which will form the "gold standard" for the diagnosis of polyp histology.

The CADx support tool operates when the Clinician switches the preconfigured CAD EYE function on using a button on the controller while the scope system is in BLI mode. This is performed after the Clinician first makes an optical prediction of polyp histology using IEE as described. The CADx support tool will make a prediction of polyp histology as "hyperplastic" or "neoplastic".

Computer-aided diagnosis (CADx) support tool

Dr James Li

Colorectal cancer (CRC) is a leading cause of cancer-related morbidity and mortality worldwide, with rates of CRC predicted to increase. Colonoscopy is currently the gold standard of screening for CRC. Artificial intelligence (AI) is seen as a solution to bridge this gap in adenoma detection, which is a quality indicator in colonoscopy. AI systems utilize deep neural networks to enable computer-aided detection (CADe) and computer-aided classification (CADx). CADe is concerned with the detection of polyps during colonoscopy, which in turn is postulated to help decrease the adenoma miss-rate.

In contrast, CADx deals with the interpretation of polyp appearance during colonoscopy to determine the predicted histology. Prediction of polyp histology is crucial in helping Clinicians decide on a "resect and discard" or "diagnose and leave strategy". It is also useful for the Clinician to be aware of the predicted histology of a colorectal polyp in determining the appropriate method of resection in terms of safety and efficacy. While CADe has been studied extensively in randomized controlled trials, there is a lack of prospective data validating the use of CADx in a clinical setting to predict polyp histology.

The investigators plan to conduct a prospective, multi-centre clinical trial to validate the accuracy of CADx support for prediction of polyp histology in real-time colonoscopy.

Colonoscopy is currently the gold standard of screening for CRC. A 1% increase in adenoma detection rate (ADR) estimated to be associated with a 3% decreased risk of interval CRC. AI systems can be broadly divided into CADe (for detection) and CADx (for diagnosis, or prediction of polyp histology in the context of colonoscopy). CADe has been extensively studied, with several randomized controlled trials and meta-analysis showing a higher ADR when CADe is used compared to the control groups without CADe.

Besides the ADR, predicted polyp histology is a key component in the performance of colonoscopy as this enables the Clinician to make a decision regarding its management, as described above. In this regards, image-enhanced endoscopy (IEE) is often used to help Clinicians determine if colorectal polyps found on colonoscopy are neoplastic or hyperplastic. The most commonly used non-magnification classification is the NBI International Colorectal Endoscopic (NICE), while the Japan NBI Expert Team (JNET) classification is used where endoscopy systems with optical magnification and the proper training is available. However, these classification systems have varying diagnostic accuracy and interobserver agreement. Previous prospective studies looking at CADx have utilized endocytoscopy and autofluorescence imaging (CAD-AFI) with positive results. However, the major limitation in these CADx studies is that these imaging systems are costly and are not readily available in most centres worldwide. Furthermore, most Clinicians performing colonoscopies have not been trained in these modalities of imaging and will have to rely completely on the CADx function to detect polyps if these imaging modalities are used, without being able to fall back on their experience and training should there be doubts about the accuracy of a CADx diagnosis in a real-world setting.

The Fujifilm 7000 System (Fujifilm Corp., Tokyo) has been in routine clinical use in all tertiary institutions in Singapore. The CAD EYE system was developed by Fujifilm Corp to aid Clinicians in colonoscopy with CADe and CADx functions. The basic functions and handling of the colonoscope, as well as the endoscopy processing unit, are similar to what is currently available in clinical practice, with the added CAD EYE software. The controller has been configured to allow the operator to activate and deactivate the CAD function depending on the need for it. These functions can be turned on and off using a button on the controller by the Clinician. The CADe and CADx functions operate when white light and blue laser imaging (BLI) are used, respectively. This provides a unique opportunity to externally validate the use of the CADx support tool by evaluating its diagnostic accuracy with final polyp histology as the gold standard, while also comparing its performance in a clinical setting against a Clinician using IEE (which is the conventional method of predicting polyp histology in colonoscopy).

The investigators plan to conduct a prospective, multi-centre clinical trial to validate the accuracy of CADx support for prediction of polyp histology in real-time colonoscopy.

Colorectal polyps detected during colonoscopy will be resected for final histology, which will form the gold standard for evaluation of the diagnostic accuracy of the Clinician using IEE versus the CADx support tool.

Real-World Validation of an Artificial Intelligence Characterization Support (CADx) System

Real-World Validation of an Artificial Intelligence Characterization Support (CADx) System for Prediction of Polyp Histology in Colonoscopy: A Prospective Multicentre Study

Subgroups include bowel preparation, size of polyp and location

National University Hospital, Singapore

Singapore General Hospital

Tan Tock Seng Hospital

Changi General Hospital

Consultant

Hemorrhage

Coagulants

Hemostatics

spraying of Endoclot powder after EMR or ESD

All patients enrolled and submitted to EMR or ESD in several units of Italian endoscopy will be divided into two different groups: in a first group will be included patients at the endoscopic end of which will be applied EndoClotTM based on the lesion removed in addition to the treatment Standard (drug injection, electrocoagulation, metal clips). The second group, on the other hand, includes patients in whom EndoClotTM will not be used.

Before the end of the procedure neither the endoscopist nor the patient will know the group because the group to which the patient is assigned will be written in a sealed envelope that will be opened only at the end of the procedure before the endoscope extraction: The use of EndoClotTM will depend on the group to which the patient belongs.

EndoClot

Alberto Arezzo, MD

The investigators want to verify in a randomised trial, the effectiveness of EndoClotTM in preventing post-procedural bleeding after EMR (Endoscopic Mucosal Resection) or ESD (Endoscopic Submucosal Dissection) for sessile lesions \>20 mm in the right colon

Additive Hemostatic Efficacy of EndoClot After EMR or ESD in the Gastrointestinal Tract

Italian Multicenter Prospective Randomized Trial to Compare Additive Hemostatic Efficacy of EndoClot System to Prevent Bleeding After Endoscopic Mucosal Resection or Endoscopic Submucosal Dissection of Lesions in the Gastrointestinal Tract

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of a Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia	NCT01384240	Colon Polyps Colonic Dysplas... Anal Dysplasia	Proflavine Hemi...	18 Years -	Anandasabapathy, Sharmila, M.D.
Evaluation of a Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia	NCT01384240	Colon Polyps Colonic Dysplas... Anal Dysplasia	Proflavine Hemi...	18 Years -	Anandasabapathy, Sharmila, M.D.
Optical Polyp Testing for In Vivo Classification	NCT03139942	Colonic Polyp Colonic Disease... Colonic Neoplas... Colonic Adenoma Colonic Adenoca... Colonic Dysplas... Colonic Carcino... Colonic Cancer Colon Hyperplas...	Optical spectra...	18 Years -	Imperial College London
Evaluation of a Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia	NCT01384240	Colon Polyps Colonic Dysplas... Anal Dysplasia	Proflavine Hemi...	18 Years -	Anandasabapathy, Sharmila, M.D.
Study of Performance of Confocal Endomicroscope With Fluorescein Imaging Agent in the Colon	NCT03220711	Colonic Dysplas... Adenomatous Pol... Irritable Bowel...	confocal endomi... Fluorescein	18 Years - 100 Years	University of Michigan
Real-World Validation of an Artificial Intelligence Characterization Support (CADx) System	NCT05034185	Colonic Polyp Colonic Neoplas... Colonic Dysplas...	Computer-aided ...	40 Years -	Changi General Hospital
Additive Hemostatic Efficacy of EndoClot After EMR or ESD in the Gastrointestinal Tract	NCT02688699	Colonic Polyp Colonic Neoplas... Colonic Dysplas...	EndoClot	18 Years -	University of Turin, Italy

Spots Global Cancer Trial Database for colonic dysplasia