Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Syndrome

Polyps

Colorectal Neoplasms

Colorectal Neoplasms, Hereditary Nonpolyposis

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Neoplastic Syndromes, Hereditary

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Genetic Diseases, Inborn

DNA Repair-Deficiency Disorders

Metabolic Diseases

When the patient is randomized for LCI, the imaging mode is switched to LCI and colonoscopic inspection will take place during withdrawal of the endoscope

When the patient is randomized for HD-WLE, the imaging mode is switched to HD-WLE and colonoscopic inspection will take place during withdrawal of the endoscope.

Participants will be randomized towards colonoscopy withdrawal with either LCI or HD-WLE

Colonoscopy

The aim of the present study is to compare polyp detection rates of LCI with high-definition white light endoscopy (HD-WLE) in patients with Lynch syndrome in a parallel, international, multicenter, randomized controlled colonoscopy trial

Rationale: Linked Color Imaging is a push-button endoscopic imaging technique developed to enhance the visibility of the vasculature and architecture of the mucosal surface by narrowing the spectrum of absorbed light. Compared to High-Definition White Light Endoscopy, mucosal surface patterns are better visualized and this could potentially increase the detection of polyps by improving the visibility of colorectal polyps. Patients with Lynch syndrome have accelerated carcinogenesis and even the smallest polyps have malignant potential. Increasing polyp detection rates with new imaging techniques is therefore of importance.

Objective: To compare polyp detection rates of Linked Color Imaging with High-Definition White Light Endoscopy during surveillance colonoscopy in Lynch patients Study design: international, multicentre, parallel, randomized controlled trial Inclusion criteria: Patients diagnosed with Lynch syndrome (proven germline mutation in one of the following MMR genes: MLH1, MSH2, MSH6 or PMS2) aged ≥ 18 years old undergoing surveillance colonoscopy Exclusion criteria: Patients who underwent recent surveillance colonoscopy within 1 year from current exam (e.g. after piecemeal EMR) or patients referred for endoscopic evaluation of known colorectal neoplasia. Patients in whom the colonoscopy is planned for the evaluation of symptoms like rectal blood loss, recent change in bowel habits, weight loss or anemia. Patients with a concurrent diagnosis of (serrated) polyposis syndrome or inflammatory bowel disease. Patients who are unwilling or unable to give informed consent.

Intervention: Included patients will undergo surveillance colonoscopy with either Linked Color Imaging colonoscopy or High-Definition White Light Endoscopy after 1:1 randomization.

Main study parameters/endpoints: Polyp detection rate of Linked Color Imaging versus High-Definition White Light Endoscopy Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Each colonoscopy is associated with a small, but not negligible risk of bleeding (\~1.5%) or perforation (\~0.1%). The use of LCI does not increase the risk of endoscopy.

An international, multicenter, parallel randomized controlled trial.

Linked Color Imaging Versus High-definition White Light Endoscopy for the Detection of Polyps in Patients With Lynch Syndrome (LCI-LYNCH)

Linked Color Imaging Versus High-definition White Light Endoscopy for the Detection of Polyps in Patients With Lynch Syndrome. An International, Multicenter, Parallel Randomized Controlled Trial.

The aim of the present study is to compare polyp detection rates of LCI with high-definition white light endoscopy (HD-WLE) in patients with Lynch syndrome in a parallel, international, multicenter, randomized controlled colonoscopy trial.

FUJIFILM Europe GmbH

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Prof. Evelien Dekker, MD, PhD

Carcinoma

Colonic Neoplasms

Adenocarcinoma

Adenoma

Colonic Polyps

Hyperplasia

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pathological Conditions, Anatomical

Intestinal Polyps

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Linked Color Imaging Versus High-definition White Light Endoscopy for the Detection of Polyps in Patients With Lynch Syndrome (LCI-LYNCH)	NCT03344289	Lynch Syndrome Colonoscopy	Colonoscopy	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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
Linked Color Imaging Versus High-definition White Light Endoscopy for the Detection of Polyps in Patients With Lynch Syndrome (LCI-LYNCH)	NCT03344289	Lynch Syndrome Colonoscopy	Colonoscopy	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Spots Global Cancer Trial Database for advanced imaging techniques