Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Every patient referred to our center for upper gastrointestinal endoscopy for investigation and/or resection of gastric neoplastic lesion can join the cohort of this study and will benefit from diagnosis and treatment by experienced endoscopists.

Evaluation of the proportion of gastric neoplastic lesions detected by a computer-aided diagnosis system (CADx) compared with experienced endoscopists.

Pierre LAFEUILLE, MD

Matthieu PIOCHE, MD

Mathieu PIOCHE, MD

Laurent MAGAUD, CRA

Upper gastrointestinal (GI) cancers are one of the most common cancers worldwide. Except for cardia cancers, the incidence of gastric cancer has decreased consistently since 1980, but remains at a high level. In France, gastric cancers are the 6th most common cause of cancer-related mortality. The risk factors of upper GI cancers are well known and their control could prevent the development of cancers: smoking cessation, reduction of obesity, alcohol, eradication of Helicobacter pylori. But late presentation with upper GI cancer results in a poorer prognosis. Patients with advanced (Stage IV) gastric cancer have a five-year survival rate of 3.7% whereas patients whose gastric cancer is discovered in its early stage (Stage I) have a significantly higher five-year survival rate of 88.4%. Therefore, endoscopic detection of upper GI lesions at an earlier stage is the single most effective measure for reducing cancer mortality. But upper GI cancer is also often missed during examinations, and some studies demonstrated a missed cancer rate of 2.3-13.9% in Western populations. In the past decade, accurate diagnosis during endoscopy has become particularly important as dysplastic lesions and early gastric cancers can be treated effectively with both endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), avoiding the morbidity and mortality associated with gastrectomy. However, these early neoplastic lesions can be sometimes difficult to distinguish from background mucosa, even with advanced imaging techniques (high definition, chromoendoscopy).

In recent years, image recognition using artificial intelligence (AI) with deep learning has dramatically improved and opened the door to more detailed image analysis and real time application in various medical field, including endoscopy. For example, in the colorectal cancer screening area, real time computer-aided detection systems (CADe) can lead to significant increases in both polyp and adenoma detection rates.

CADe has also shown good performance in detection of Barrett's neoplasia during live endoscopic procedures in order to more accurately locate the area to be biopsied. Recently, a Chinese study showed that CADe achieved high diagnostic accuracy in detecting upper GI cancers, with sensitivity similar to that of expert endoscopists and superior to that of non-experts. This system could support non-experts by improving their diagnostic accuracy to a level similar to that of experts and provide assistance for improving the effectiveness of upper GI cancer diagnosis and screening.

Although encouraging results have been published regarding the use of AI in the diagnosis of upper GI cancers, the clinical applicability of such systems in a European population has yet to be investigated.

Therefore, we want to evaluate the diagnostic capability of a recent CADx compared to endoscopists in order to improve the real-time detection of early gastric cancers in our European center Edouard Herriot Hospital, Lyon, France, as well as 3 other tertiary centers in France (Limoges, Rennes and Nancy University Hospitals).

With a high prevalence of stomach cancer, Japan is a world leader in high-quality diagnostic upper GI endoscopy, and the clinical routine in this country differs substantially from Western practice, with population-based screening programs. We will use for our study a CADx developed by AI medical service Inc. (1-18-1, Higashiikebukuro, Toshima-ku, Tokyo 170-0013, Japan), a Japanese company developing AI systems that supports endoscopist's diagnosis for the digestive tract. A recent study involving AI medical service system showed good results in the diagnosis of early gastric cancer compared to endoscopists, with a significantly higher sensitivity.

Evaluation of a Computer-aided Diagnosis System (CADx) in the Early Detection of Gastric Cancer in France. Cancer in France.

Early Detection of Gastric Cancer in France: Evaluation of the Diagnostic Capacity of a Computer-aided Diagnostic System (CADx) Compared to Endoscopists. EGC-France

Hospices Civils de Lyon

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Every patient who needs diagnostic colonoscopy because of digestive symptoms, medical or family history of colorectal cancer/polyps, positive colorectal screening test, acromegaly or referred by another gastroenterologist upon discovery of colorectal polyp after colonoscopy can join the cohort of this study and can get CONECCT's classification histological assessment of their neoplastic lesion by experienced endoscopist.

Colorectal neoplastic lesion endoscopic characterization is a key element for histological predictive diagnostic value in conducting best appropriate resection choice. Six classifications are necessary for fully correct characterization of different colorectal lesions. Nonetheless, it can be tricky to use so many diagnostic tools with so many subcategories in the 6 existing classifications. That's why we decided to integrate all 6 existing classification validated factors in one single chart (CONECCT chart) allowing to both predict histological diagnostic value and to propose the best appropriate resection strategy. A previous prospective and multicentre study with all French medical residents in gastroenterology was conducted in order to prove pedagogic interest of this diagnostic tool. Each student was asked to review 20 files with lesion pictures before and after lecture about CONECCT chart. This allowed us to prove that this diagnostic tool could significantly improve both histological predictive diagnostic value and therapeutic choice by French medical residents and gastroenterologists. Our hypothesis is that CONECCT's classification can improve predictive diagnostic value of colorectal lesions in over 80% of cases. Now that pedagogic interest of this diagnostic tool has been proven, we would like to carry out a larger prospective assessment in term of performance (value) of this instrument in order to both facilitate endoscopic characterization and allow a most appropriate diagnostic and therapeutic management of each colorectal lesion category.

Prospective Assessment of CONECCT's Classification for Colorectal Lesions.

Prospective Assessment of CONECCT's Classification for Histological Predictive Diagnostic Value in Conducting Therapeutic Choice for Colorectal Lesions. Pro-CONECCT

assessed by one of research site operators and final histology reading of neoplastic lesion by anatomopathologist:

* CONECCT 0E : neuroendocrine tumor
* CONECCT IH : hyperplastic polyp
* CONECCT IS : sessile serrated lesion with or without dysplasia
* CONECCT IIA : low or high grade adenoma
* CONECCT IIC : low or high grade adenoma or intramucosal or submucosal \<1000 micron adenocarcinoma
* CONECCT III : deep invasive submucosal \> 1000 microns adenocarcinoma

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Infective Agents

Antineoplastic Agents

Anesthetics

Ciprofloxacin

All patients in the study will receive a scan of their prostate with the novel UreScan machine. All scans will be evaluated in their accuracy of detecting cancer loci within the prostate as compared to histopathological reviews of the prostate post robotic prostatectomy.

The TUUS Foley/catheter will be inserted into the urethra via the ultrasound visualization onto the apex prostate, and the ultrasound extended through the urethra until the bladder neck and stopped. This is recorded twice automatically, and this should take 5-10 minutes for completion, and the prostate ultrasound data stored in memory. The ultrasound/subject interaction is now complete, and the study should add 30-60 minutes to the preoperative visit. No local or general anesthesia is used. The subject will be given 500 mg of Ciprofloxacin as a preventative measure against a urinary tract infection.

UreScan

Thomas E Ahlering, MD

This study is being performed to verify the ability to use minimally invasive transurethral ultrasonic imaging technology for the purpose of identifying prostate cancer. Transurethral ultrasonic prostate imaging, may in the future, be used for detection and monitoring these disease processes to minimize the need for obtaining surgical biopsy specimens. The hypothesis is that tissue-density variations, as revealed in diagnostic ultrasonic imaging, results in unique image signatures for identification of prostate cancer. This imaging procedure provides a multifaceted view of the entire in-situ gland.

The current use of Prostate Specific Antigen (PSA) for determining the likelihood of presence of cancer in the prostate gland requires interpretation and has a good but limited to predict prostate cancer on biopsy, with significant false prediction rates. More importantly as a blood test, the PSA test lacks the ability to pinpoint the location of the cancer within the prostate gland. Preliminary study findings have suggested that "Transurethral Ultrasonic Scanning" (TUUS) presents the desired improved diagnostic sensitivity for detection of cancer within the imaged prostate gland, and has the intrinsic capability to provide high resolution images of the transverse and future three-dimensional views of the entire gland better than currently used Transurethral Ultrasound (TRUS). Two important goals of the practicality of this minimally invasive technology will be assessed by this study. 1. The ability of TUUS to directly detect prostate cancer locations in the prostate. 2. The use of TUUS to successfully guide the prostate needle biopsy to cancer loci with a high rate accuracy.

The Purpose of the Research The primary objective of this Institutional Review Board-controlled study is to determine if the presently manually-read results of TUUS data obtained with the novel UreScan device can be correlated with pathologist findings in a harvested prostate gland from an individual with diagnosed prostate disease. If successful, a future Institutional Review Board study will explore the use of computer software to examine the 256 transverse image slices of a large number of prostate cancer patients to establish the clinical applicability of TUUS for screening and assessment of individuals with elevated levels of PSA and/or positive digital rectal examinations (DRE), potentially reducing the number of future biopsy examinations with false-positive findings.

Background Information The current use of Prostate Specific Antigen for determining the likelihood of presence of cancer in the prostate gland has been shown to be seriously flawed. Multiple studies reviewing the findings of referred biopsies, based on elevated PSA levels, resulted in as many as 70% false positive findings for cancer. Improved rapid, minimally-invasive, low-cost methodology and technology should be developed to provide diagnostic cancer findings that have higher sensitivity and specificity is the objective goal of the present research. Preliminary study findings have suggested that "Transurethral Ultrasonic Scanning" (TUUS) presents the desired improved diagnostic sensitivity for detection of cancer within the imaged prostate gland and has the intrinsic capability to provide high resolution images of the transverse and future three-dimensional views of the entire gland. Two important goals of this minimally invasive technology will be assessed by this study. 1. The ability of TUUS to directly detect prostate cancer in situ in the prostate. 2. The use of TUUS to successfully guide the prostate needle biopsy to cancer loci with a high rate accuracy.

In a 2003 study by Holmes et al, the TUUS device was tested on 2 patients who had seeds implanted for prostate cancer. TUUS revealed more seeds (82%, 84%) than standard TRUS (63%, 65%) in the 2 patients. These simple cases demonstrated the feasibility of providing transverse images of the entire prostate gland. Holmes postulated that this procedure would have to be automated to achieve any clinical utility value and the project essentially was abandoned by Mayo.

The TUUS/"UreScan" system is a marriage of an off label usage of the FDA approved vascular probe, placed inside a standard foley catheter which is inserted into the penis onto the prostate to the neck of the bladder. The ultrasound probe travels the length of the prostate (\~4-8cm) within the sheath of the catheter and images the entire prostate with ultrasound. The travel of the ultrasound probe is controlled by a small motor which is driven from outside the catheter and patient as well. This motor driven probe offers the possibility of accurate and reproducible ultrasounds of the prostate, as the patient's prostate apex is used the anchor point for study.

Refinements to the TUUS system include:

1. A Foley type introducer should be used for placing the intravascular ultrasound transducer in the prostatic urethral region to be imaged
2. Use of a fixed-position, ultrasonic coupling gel-coated Introducer to eliminate the possibility of urethral abrasion or trauma as might otherwise occur without the Introducer when moving the transducer within the prostatic imaging region.
3. Insertion into the Introducer of the wire-rotationally-driven ultrasonic transducer as coated with sterile water ultrasonic coupling between the transducer and introducer
4. The examiner would then initiate the automated scanning procedure with analog/digital video data for each of 256 transverse axial image slices of the prostate gland. The scanning of the gland can be stopped or started at the election of the examiner
5. A video-media record of the images derived from the procedure is available to an experienced reader for interpretation.

The initial UreScan hydrophone verified specifications included: 1. 256 transverse, automatically axially advanced, image slices. 2. Approximately 267 megabits of video data. 3. Diagnostic ultrasound scanning of 100 revolutions per minute at 9.0 M Megahertz. 4. Radial penetration of 6 cm. The scanner features:

1. The amplitude of reflected ultrasonic echoes from biological tissue, as displayed by a density-based oscillogram is directly proportional to the density of the tissue being insonated in an adjusted flat far-gain ultrasonic system.
2. Longitudinal time-related, ultrasonic densitometry and image-registered comparisons of sonograms have demonstrated progression and/or regression of disease consistent with efficacy of treatment procedures. This facilitates future "wait and watch surveillance" of known or suspected lesions while potentially minimizing and/or eliminating unnecessary surgical biopsy tissues procedures
3. The reflected echo waveform and sonogram has been shown to be unique for each type of disease entity. In prostate disease, there is a unique difference between the image-markers for prostate cancer and normal tissue.

The present study protocol is to determine if image-markers for cancer and other unique prostate pathology can be specifically identified. Further clinical studies will be required to determine sensitivity, specificity, accuracy and (+/-) predictor values of this procedure. Additional studies will be required to determine if the amplitude of the image-markers could be used for determining the approximate stage of the image detected disease processes.

Transurethral Ultrasonic Imaging For Detection and Classification of Prostate Cancer

The primary objective of this Institutional Review Board -controlled study is to determine if Trans urethral ultrasound can be used to identify prostate cancer, thus avoiding prostate needle biopsies for diagnosis

University of California, Irvine

Vice Chairman and Professor

All patients in the study will receive a scan of their prostate with the novel UreScan machine. All scans will be evaluated in their accuracy of detecting cancer loci within the prostate as compared to histopathological reviews of the prostate post robotic prostatectomy.

UreScan: The TUUS Foley/catheter will be inserted into the urethra via the ultrasound visualization onto the apex prostate, and the ultrasound extended through the urethra until the bladder neck and stopped. This is recorded twice automatically, and this should take 5-10 minutes for completion, and the prostate ultrasound data stored in memory. The ultrasound/subject interaction is now complete, and the study should add 30-60 minutes to the preoperative visit. No local or general anesthesia is used. The subject will be given 500 mg of Ciprofloxacin as a preventative measure against a urinary tract infection.

All Patients

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Thomas Ahlering, MD

Data were not collected because the study was discontinued due to lack of feasibility and negative results.

Measure Novel Transurethral Ultrasound Signatures to Detect Prostate Cancer

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of a Computer-aided Diagnosis System (CADx) in the Early Detection of Gastric Cancer in France. Cancer in France.	NCT05928819	Gastric Cancer	Evaluation of t...	18 Years -	Hospices Civils de Lyon
Prospective Assessment of CONECCT's Classification for Colorectal Lesions.	NCT05983315	Colorectal Canc...		18 Years -	Hospices Civils de Lyon
Transurethral Ultrasonic Imaging For Detection and Classification of Prostate Cancer	NCT02307552	Prostate Cancer	UreScan	40 Years - 80 Years	University of California, Irvine

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