Neoplasms

All Conditions

Symptoms and General Pathology

Adenoma

Colonic Polyps

Polyps

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Polyps

Pathological Conditions, Anatomical

Patients undergoing colonoscopy with artificial intelligence.

We wanted to compare the diagnostic yield obtained by using CADe colonoscopy to the yield obtained by the standard colonoscopy (SC) in a follow-up pateints in the screening population.

CADe colonoscopy using GI Genius device

White light

Daniele Salvi

Paola Cesaro

daniele salvi

Cristiano Spada

The goal of this clinical trial is to evaluate the diagnostic yield of CADe in a consecutive population undergoing colonoscopy. The main question it aims to answer is the Adenoma Detection Rate (ADR). Participants undergoing colonoscopy for follow-up in a screening setting will be randomized in a 1:1 ratio to either receive Computer-Aided Detection (CADe) colonoscopy or a conventional colonoscopy (CC). GI Genius is the AI software that will be used in the present trial and is intended to be used as an adjunct to colonic endoscopy procedures to help endoscopists to detect in real time mucosal lesions (such as polyps and adenomas, including those with flat (non-polypoid) morphology) during standard screening and surveillance endoscopic mucosal evaluations. It is not intended to replace histopathological sampling as a means of diagnosis.Researchers will compare the CADe group and the CC-group to see if CAD-e can increase the ADR significantly.

en if colonoscopy is considered the reference standard for the detection of colonic neoplasia, polyps are still missed. In large administrative cohort or case-control studies, the risk of early post-colonoscopy cancer appeared to be independently predicted by a relatively low polyp/adenoma detection rate. The adenoma detection rate among different endoscopists has been shown to be strictly related with the risk of post-colonoscopy interval cancer. When considering the very high prevalence of advanced neoplasia in the FIT-positive enriched population, the risk of post-colonoscopy interval cancer due to a suboptimal quality of colonoscopy may be substantial. Available evidence justifies therefore the implementation of efforts aimed at improving adenoma detection rate, based on retraining interventions and on the adoption of innovative technologies, designed to enhance the accuracy of the endoscopic examination.Nowadays, Artificial intelligence (AI) is gaining increased attention and investigation, since it seems to improve the quality of medical diagnosis and treatment. In the field of gastrointestinal endoscopy, two potential roles of AI in colonoscopy have been examined so far: automated polyp detection (CADe) and automated polyp histology characterization (CADx). CADe can minimize the probability of missing a polyp during colonoscopy, thereby improving the adenoma detection rate (ADR) and potentially decreasing the incidence of interval cancer. GI Genius is the AI software that will be used in the present trial. The software is developed by Medtronic Inc. (Dublin, Ireland) and is intended to be used as an adjunct to colonic endoscopy procedures to help endoscopists to detect in real time mucosal lesions (such as polyps and adenomas, including those with flat (non-polypoid) morphology) during standard screening and surveillance endoscopic mucosal evaluations. It is not intended to replace histopathological sampling as a means of diagnosis.

The objective of this study was to compare the diagnostic yield obtained by using CADe colonoscopy to the yield obtained by the standard colonoscopy (SC). As the risk of progression is higher for large than for small adenomas the specific contribution of the new technique in reducing the miss rate of large neoplasms represents an important outcome to be assessed in the study. In addition, given the suggested association of a higher miss-rate of serrated and flat lesions with an increased risk of early post-colonoscopy CRC, the benefit of the new technique in reducing the miss rate of these lesions will be assessed.

Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in Follow-up Patients in a Screening Setting

The percentage of patients with adenomas with high-grade displasia in CADe colonoscopy group will be recorded and compared with the rate of patients with adenomas with high-grade displasia in standard colonoscopy group.

The percentage of patients with 3 or more adenomas (serrated adenomas will also be considered in the calculation) in CADe colonoscopy group will be compared with the rate of patients with 3 or more adenomas (including serrated adenomas) in standard colonoscopy group.

The percentage of adenomas, polyps (in general), flat adenoma and serrated polyps/adenoma detected will be recorded and compared between the groups.

The size of lesion detected will be measured in millimiters and compared between the groups.

The percentage of patients with neoplasia of proximal (right colonic segments) or distal (left colonic segments and rectum) site will be assessed and compared between the groups.

the time interval, expressed in years, to the next suggested follow-up colonoscopy will be assessed and compared between the groups.

The time to reach the cecum will be measured in minutes, recorded and compared between the groups.

The time of withdrawal (from cecum to anus) and of the overall colonoscopy (from anus to anus) will be measured in minutes, recorded and compared between the groups.

The above-mentioned outcomes will be calculated for each endoscopist at 3, 6, 9 and 12 months.

Proportion of patients diagnosed with polyps which were detected only by Artificial intelligence

Fondazione Poliambulanza Istituto Ospedaliero

Skin and Connective Tissue Diseases

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Dermatologic Agents

All Drugs and Chemicals

Methyl 5-aminolevulinate

Aminolevulinic Acid

Photosensitizing Agents

Only patients with a minimum of 9 clinically diagnosed grade I and II AK lesions of the scalp (according to the classification by Olsen et al. suggesting the existence of field cancerization, are included in the study. All patients are informed about the purpose of the study and gave informed consent before inclusion. The illumination begins 10 min after the application of MAL cream to the treatment area. In this study, the duration of the light exposure is reduced to 35 min to achieve a PpIX-weighted daylight of 4 J/cm2. MAL cream is removed after the illumination procedure leading to an incubation time of 45 min.

Metvix + Dermaris

This clinical study aims aims to evaluate the clinical outcomes of SDL-PDT (simulated daylight Photodynamic Therapy) using the Dermaris in patients treated for AK lesions of the scalp at our medical dermatology center using only 35 minutes low-intensity light exposure.

25 patients, with phototype 1 to 3, with grade I-II AK of the scalp will be treated. Only patients with a minimum of 9 clinically diagnosed grade I and II AK lesions of the scalp (according to the classification of Olsen) suggesting the existence of field cancerization, will treated with SDL-PDT (simulated daylight Photodynamic Therapy) using the Dermaris® (Surgiris, France) and therefore included in the study after application of MAL cream (Metvix ®, Galderma, Switzerland) to the treatment area. After debridment of all treated areas with sandpaper, Metvix will be applied and illuminated with with Dermaris 10 minutes later (leading to drug-light interval (DLI) of 10 minutes) with an irradiance of 2.9 mW/cm2 and a duration of 35 minutes The primary endpoint will be the rate of patients with less than two AK lesions at six-month post-treatment. Secondary endpoints will include scores of pain, erythema, crusts, discomfort and during or/and post the treatment.

A ﬁrst follow-up visit will be scheduled seven days after the treatment. At this visit, crusts will be clinically rated by a dermatologist, while patients scored discomfort they had experienced during the six-day post-treatment. At the second follow-up visit conducted three months after the treatment, AK lesions will be counted by a dermatologist without differentiation between new and recurrent lesions. A second SDL-PDT using the Dermaris will be performed on the day if AK lesions are still present. At last, in case of remaining AK observed at 6 month follow up, a third treatment session with the same parameters will be carried out.

The study is approved by the Ethical clinical committee of the Centre Dermatologique du Roy and conducted in accordance with the ethical principles of the Declaration of Helsinki (2008) and the International Conference on Harmonisation - Good Clinical Practices and in compliance with local regulatory requirements.

Clinical Evaluation of a Short Illumination Duration (35 Minutes) When Performing PDT of AK Using the Dermaris ®

Clinical Evaluation of a Short Illumination Duration (35 Minutes) When Performing Photodynamic Therapy of Actinic Keratosis Using the Dermaris ®

Individual Participant Data (IPD) will be available thanks to an article published in a peer-reviewed open access journal.

The number of removed lesions at six-month post treatment will be expressed as percentage: number of removed lesions divided by number of lesions at patients' inclusion.

A Visual Analogue Scale (VAS) will be used to measure pain intensity. The VAS consists of a 10cm ruler used to measure the distance in centimeters from the 'no pain marker' (or zero) to the current pain mark. This will provide a pain intensity score out of 10; for example, 6 out of 10 (or 6/10).

Discomfort during the treatment, which arises from the need for patients to stay under the Dermaris during the 35 minutes of photoactivation, includes joint pain, fatigue, refraining from going to the toilet will be assessed thanks to a specific questionnaire Similarly, discomfort during the six-day post-treatment, which refers to patients' quality of life, includes difficulty to sleep well, inconvenience in head care, embarrassment for outings will be assessed thanks to a specific questionnaire.

At six-day post-treatment, the crusts will be rated using a 6-point scale (0 stands for no crusts, 1 for very mild crusts, 2 for mild crusts, 3 for moderate crusts, 4 for severe crusts and 5 for very severe crusts). The presence of an erythema will be noted. 0: no erythema; 1: erythema.

Centre Dermatologique du Roy

Digestive System Diseases

Colorectal Neoplasms

Inflammatory Bowel Diseases

Intestinal Diseases

Gastrointestinal Diseases

Gastroenteritis

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Colonic Diseases

Rectal Diseases

Herbal and Botanical

Methylene Blue

Cola

Similar to single-pass HDWLE, with a second segmental inspection after the first examination in the same session. Equipment is similar to 1.

Using HD white light, the entire colon is examined for dysplasia and other abnormalities after the caecum is reached. The colonoscope has a high-definition camera and processor. All images are displayed on a high definition monitor for optimal resolution.

After introduction of the endoscope into the colon a dye (methylene blue or 0.3% indigo carmine) will be sprayed through a catheter positioned into the biopsy channel. Per segment, the entire colon is dyed, inspected, and lesions are removed. Equipment is similar to the other two arms.

Using HD white light, the entire colon is examined for dysplasia and other abnormalities after the caecum is reached, with a second segmental inspection after the first examination in the same session.The colonoscope has a high-definition camera and processor. All images are displayed on a high definition monitor for optimal resolution.

Back-to-back high-definition white light endoscopy

single-pass high-definition white light endoscopy

After introduction of the endoscope into the colon a dye (methylene blue or indigo carmine) will be sprayed through a catheter positioned into the biopsy channel. Per segment, the entire colon is dyed, inspected, and lesions are removed. Equipment is similar to the other two interventions.

chromoendoscopy

Frank Hoentjen, MD PhD

Bas Oldenburg, MD PhD

The current international guidelines for CRC surveillance in IBD recommend as first choice the use of chromoendoscopy, and as an alternative high-definition white light endoscopy (HDWLE) for optimal dysplasia detection, based on data from clinical trials. However, data on the superiority of CE over HDWLE are not consistent in literature. The investigators hypothesize that the better performance of CE in some clinical trials is the result of the associated longer procedural time and the fact that every colon segment is examined twice. Currently, no studies have been published evaluating the dysplastic yield of back-to back HDWLE compared to HDWLE with a single pass or CE in patients with IBD. In the present study, the investigators aim to compare the yield of dysplasia/CRC between 1) regular HDWLE, 2) HDWLE back-to-back, and 3) CE.

The investigators assume based on previous research a yield of 12% using high-definition white light endoscopy and 24% using either chromoendoscopy or high-definition white light endoscopy with a second examination (Imperatore et al 2019). To show non-inferiority of back-to-back HDWLE compared to CE, with a non-inferiority margin of 10% (power 80% and alpha 5%,) a total of 226 patients per group is required.

To demonstrate a superiority of back-to-back HDWLE compared to a regular HDWLE, with a 1:2 allocation ratio of single-pass vs back-to-back , 113 and 226 patients per group are needed to achieve 80% power with an alpha of 5%. Therefore, the investigators will include 226 patients in group back-to-back HDWLE, 226 in group CE, and 113 patients in group regular HDWLE. This amounts to a total of 560 patients. To account for any screen-failures The investigators will include at most 5% (of 560) additional patients until 80% power is reached.

This is a multicenter, non-blinded randomized trial with three parallel arms: back-to-back HDWLE, single-pass HDWLE and CE.

Back-to-back Endoscopy Versus Single-pass Endoscopy and Chromoendoscopy in IBD Surveillance

Back-to-back High-definition White Light Endoscopy Versus Single-pass High-definition White Light Endoscopy and Chromoendoscopy in IBD Surveillance

Total endoscopic procedure time and endoscopic procedure time during withdrawal for each technique.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in Follow-up Patients in a Screening Setting	NCT06160466	Colonic Adenoma Adenoma Polyp of Colon	CADe colonoscop... White light	50 Years - 74 Years	Fondazione Poliambulanza Istituto Ospedaliero
Clinical Evaluation of a Short Illumination Duration (35 Minutes) When Performing PDT of AK Using the Dermaris ®	NCT05522036	Actinic Keratos...	Metvix + Dermar...	18 Years - 99 Years	Centre Dermatologique du Roy
Clinical Evaluation of a Short Illumination Duration (35 Minutes) When Performing PDT of AK Using the Dermaris ®	NCT05522036	Actinic Keratos...	Metvix + Dermar...	18 Years - 99 Years	Centre Dermatologique du Roy
Back-to-back Endoscopy Versus Single-pass Endoscopy and Chromoendoscopy in IBD Surveillance	NCT04291976	Inflammatory Bo... Colorectal Neop...	Back-to-back hi... single-pass hig... chromoendoscopy	18 Years -	Radboud University Medical Center

Spots Global Cancer Trial Database for white light

Every month we try and update this database with for white light cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for white light

Every month we try and update this database with for white light cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for white light cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.