Neoplasms

Digestive System Diseases

All Conditions

Barrett Esophagus

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Diseases

Physician will complete a VLE scan of the esophagus and target areas of interest using the VLE optical marking probe following standard of care endoscopy

Physician will complete a VLE scan of the esophagus and target areas of interest using the VLE optical marking probe

NvisionVLE with Real Time Targeting

esophagogastroduodenoscopy (EGD)

Kenneth Wang, MD

The NvisionVLE® Dysplasia Detection Pilot Study is a prospective, non-randomized trial for participants who have a prior biopsy-confirmed diagnosis of BE with dysplasia and are scheduled to have an endoscopic evaluation of your esophagus for BE surveillance by a standard procedure called EGD (esophagogastroduodenoscopy) as well as an imaging procedure called VLE (volumetric laser endomicroscopy).

The NvisionVLE® Dysplasia Detection Pilot Study is a collection of data for research. Participation is completely voluntary and does not affect the patient's medical care that chooses not to participate. The purpose of this Study is to determine the performance of the NvisionVLE® Imaging System in determining features of dysplastic Barrett's Esophagus (BE). This is done by the collection and analysis of the medical record information, imaging data, and pathology results. The information is then stored and may be used at a later time for various future analyses and publications. Any future analyses involving this Study will only use the information collected in this Study. No further involvement or additional informed consent of participants will be needed if future analyses are performed.

This Study is designed for participants who have a prior biopsy-confirmed diagnosis of BE with dysplasia and are scheduled to have an endoscopic evaluation of your esophagus for BE surveillance by a standard procedure called EGD (esophagogastroduodenoscopy) as well as an imaging procedure called VLE (volumetric laser endomicroscopy).

The NvisionVLE® Imaging System is cleared for use by the U.S. Food and Drug Administration (FDA).

Patients who undergo an endoscopic evaluation of the esophagus with the NvisionVLE® Imaging System at participating hospitals will be invited to participate in this Study. The Study is taking place at up to 4 hospitals, and as many as 100 patients may participate in this Study.

Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System

Identification of Features Associated With Dysplasia Using the NvisionVLE® Imaging System Pilot Trial

To determine the per-biopsy performance of a multivariable model consisting of manually-identified VLE features for predicting biopsy-defined dysplasia

1. To determine the absolute per-patient sensitivity and specificity of a multivariable model consisting of manually-identified VLE features for predicting biopsy-defined dysplasia.

2. To determine the absolute per-biopsy sensitivity and specificity of a multivariable model consisting of manually-identified VLE features for predicting biopsy-defined dysplasia.

3. To compare, on a per-biopsy basis, the performance of VLE and standard-of-care to standard-of-care alone in detecting dysplasia.

NinePoint Medical

Ear, Nose, and Throat Diseases

Rare Diseases

Adenocarcinoma

Esophageal Neoplasms

Deglutition Disorders

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Esophageal Cancer

Cryotherapy employs thermal ablation to treat esophageal cancer and BE. Ablation is achieved by intracellular disruption and ischemia that is produced by freeze-thaw cycles using liquid nitrogen or carbon dioxide

Cryotherapy

EGD is a diagnostic procedure that allows the physician to diagnose and treat problems in the upper gastrointestinal (UGI) tract. The doctor uses a long, flexible, lighted tube called an endoscope.

Esophagogastroduodenoscopy (EGD)

EUS is a procedure that allows a doctor to obtain images and information about the digestive tract and the surrounding tissue and organs, including the lungs. Ultrasound testing uses sound waves to make a picture of internal organs.

Endoscopic ultrasound (EUS)

Vladimir M Kushnir, MD

Thomas G Hollander, RN

Esophageal adenocarcinoma (EAC) is one of the few cancers with a rising incidence in the United States, with an estimated 17,000 new cases diagnosed in 2012. Most patients with esophageal cancer present with tumors which are not amenable to surgery and are treated with chemotherapy and radiation. The most common and bothersome symptoms from esophageal cancer is dysphagia (difficulty swallowing). Chemotherapy and radiation are effective in shrinking tumors and allowing patients with EAC to swallow more easily; however it usually takes 1-2 months for swallowing to improve with this treatment.

Another method of shrinking esophageal tumors and allowing for better swallowing is endoscopic spray cryotherapy (freezing the tumor from inside the esophagus with the aid of an endoscope); cryotherapy is a well established method for treating cancerous and pre-cancerous esophageal disease. This is a particularly attractive treatment option, as patients with esophageal cancer usually undergo endoscopy on several occasions before starting treatment in order to biopsy and evaluate the tumor.

The goal of this study is to evaluate the effectiveness of cryotherapy in treating EAC related dysphagia in patients who are getting ready to start chemotherapy and radiation.

In order to do this the investigators are planning to invite patients who are already undergoing endoscopy for pre-chemotherapy evaluation of known EAC. Patients would undergo cryotherapy after the diagnostic portion of the endoscopy has been completed. After the cryotherapy patients will be contacted by phone in order to evaluate change in symptoms, 2 and 4 weeks after cryotherapy.

Endoscopic spray cryotherapy (EC) is a novel modality for destruction of tissue in the gastrointestinal tract. EC involves the endoscopic application of cryogen \[liquid nitrogen (LN)\], which destroys tissue by rapid freezing and slow thawing. Immediate effects from tissue freezing include failure of cellular metabolism, membrane damage and local ischemia. Delayed effects may include apoptosis of cancer cells and immune mediated tumor destruction. EC has been used for the treatment of mucosal EAC and palliation of malignant dysphagia since 2007 in multiple tertiary centers, including Washington University in St Louis, with positive results. EC is an attractive modality for the palliation of malignant dysphagia in EAC due to the fact that newly diagnosed patients undergo upper endoscopy (EGD) and endoscopic ultrasound (EUS) as part of initial staging; thus EC could be delivered at the time of the staging endoscopy, without burdening the patient with an additional procedure. However, prospective studies on the efficacy of EC in the short term palliation of malignant dysphagia in EAC have not been performed.

Thus, the goal of this pilot study is to evaluate the effectiveness of EC in the short term palliation of malignant dysphagia in patients with unresectable EAC.

Cryotherapy for Malignant Dysphagia in Patients With Advanced Esophageal Cancer

Palliation of Malignant Dysphagia With Spray Cryotherapy in Patients With Advanced Esophageal Cancer: A Pilot Study

Results of the re-staging PET-CT will be abstracted from the medical record to document presence or absence of a pathologic complete response

Results of the surgical explant will be abstracted from the medical record to document presence or absence of a pathologic complete response.

Hunter Holmes Mcguire Veteran Affairs Medical Center

Infections

Symptoms and General Pathology

Communicable Diseases

Stomach Neoplasms

Atrophy

Gastritis, Atrophic

Gastritis

Stomach Diseases

Chronic Graft Versus Host Disease

Stomach Cancer

This happens on Day 0. Screening for EGD, biopsy samples from esophagus, stomach, gastrointestinal junction, and duodenum AE's.

After colonoscopy, the patient will undergo the EGD at which time biopsy specimens will be obtained.

Participants will also be provided with a home stool collection kit which they can bring to the endoscopy visit or mail back. Satisfaction questions will be administered 3-7 days after EGD-SC

Haejin In, MD

Screening esophagogastroduodenoscopy (EGD )provides three distinct opportunities to decrease gastric cancer (GC) morbidity and mortality. has potential to discover cancer in early stages before the onset of symptoms, leading to higher rates of survival. Second, premalignant lesions such as adenomatous polyps, intestinal metaplasia and dysplasia can be discovered and removed with local resection, akin to polypectomies during screening colonoscopies, preventing the development of cancer. Third, EGD discovery and treatment of active Helicobacter pylori (HP) infection of the stomach provides an opportunity for primary prevention of GC.

The primary objective of the study is to evaluate the acceptability and feasibility of EGD-SC.

The secondary objectives are:

1. Estimate Median added time needed for EGD at the time of routine screening colonoscopy
2. Estimate the frequencies of adverse events
3. Estimate the percentage of pre-cancer and cancerous lesions including H. pylori infection, chronic atrophic gastritis, IM, dysplasia and GC among this high GC risk population
4. Investigate whether high-risk racial/ethnicity groups have different likelihood of uptake of EGD, and whether the likelihood is associated with patient beliefs, attitudes and knowledge of GC, perceptions of risk, motivators and barriers, and sociocultural factors, as well as patient preference and satisfaction with EGD-SC

A single-center, open label pilot study that will evaluate the acceptability and feasibility of EGD at time of routine screening colonoscopy (EGD-SC). The Pre-Study Screening is day -30 to day 0; EDG at time of routine screening colonoscopy and follow-up day five to seven.

Pilot Study of Stomach Cancer Early Detection and Prevention With Endoscopy

Primary Objective: The Primary Objective of the Study is to Evaluate the Acceptability and Feasibility of EGD-SC

Linear Scale eligible for the study. The Wilcoxon signed-rank test will be used to assess the participants responses to EGD.

To achieve the goal of assessing feasibility of EDG-SC as well as estimates of effect size needed to determine sample size and power for the planned study, the investigator will collect data on the number of participants contacted, number eligible, and number who agree to EGD-SC.

Adverse events (AEs) will be evaluated and graded using the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System	NCT02864043	Barrett's Esoph...	NvisionVLE with... esophagogastrod...	18 Years -	NinePoint Medical
Cryotherapy for Malignant Dysphagia in Patients With Advanced Esophageal Cancer	NCT02606396	Esophageal Aden...	Cryotherapy Esophagogastrod... Endoscopic ultr...	18 Years -	Hunter Holmes Mcguire Veteran Affairs Medical Center
Pilot Study of Stomach Cancer Early Detection and Prevention With Endoscopy	NCT05566899	Gastric Cancer	esophagogastrod...	40 Years - 80 Years	Rutgers, The State University of New Jersey
Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System	NCT02864043	Barrett's Esoph...	NvisionVLE with... esophagogastrod...	18 Years -	NinePoint Medical
Cryotherapy for Malignant Dysphagia in Patients With Advanced Esophageal Cancer	NCT02606396	Esophageal Aden...	Cryotherapy Esophagogastrod... Endoscopic ultr...	18 Years -	Hunter Holmes Mcguire Veteran Affairs Medical Center
Pilot Study of Stomach Cancer Early Detection and Prevention With Endoscopy	NCT05566899	Gastric Cancer	esophagogastrod...	40 Years - 80 Years	Rutgers, The State University of New Jersey

Spots Global Cancer Trial Database for esophagogastroduodenoscopy (egd)