Neoplasms

Digestive System Diseases

All Conditions

Barrett Esophagus

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Diseases

Patients in this arm is requested to swallow the esophageal capsule and then undergo standard EGD.

Patient is asked to swallow the esophageal capsule.

Pill cam

Prateek Sharma, MD

This study is to examine the benefits of newly designed capsule with enhanced frame rate and wide angle compared to standard endoscopy, which may help enhance detecting esophageal diseases that otherwise may have been out of vision in the standard endoscopy, ultimately decreasing healthcare costs.

This is a pilot, single center, prospective, tandem study. All veteran patients with Barrett's esophagus scheduled for an upper EGD at Veterans Affairs Medical Center (Kansas City, MO, USA) for check-up of BE will be asked to swallow the pillcam prior to an EGD. A member of the research team will approach a potential subject to discuss participation in the study, including background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up. If this is of interest to the subject, the informed consent form is discussed and presented. The subject must sign the consent form prior to enrollment. This form will have prior approval of the study site's Institutional Review Board (IRB). Failure to obtain informed consent renders the subject ineligible for the study

Eligible subjects at the participating institution who meet the inclusion criteria for this study will be offered the opportunity to participate in this clinical trial. To ensure that subjects are approached for potential study participation without bias, a Subject Screening Log will be maintained. This Log will track the basic demographic information of each subject approached for clinical trial inclusion and the resulting reason for exclusion from the clinical study if applicable.

The duration of the study is expected to be approximately 12 months. Enrollment of Study patients will cease when approximately 20 patients have been enrolled.

Evaluation of Performance Characteristics of Capsule Endoscopy With PillCam UGI Capsule Compared to Standard Endoscopy

Evaluation of Performance Characteristics of Capsule Endoscopy With PillCam UGI Capsule Compared to Standard Endoscopy for Screening of Barrett's Esophagus: A Prospective Tandem Study

This is a funded study. A copy of de-identified data set will be provided to the sponsor in the form of case report forms (CRF) at the end of the study.

The ability to accurately predict the presence of Barrett's esophagus by capsule endoscopy and standard EGD will be measured.

Wireless capsule endoscopy is generally considered safe. Potential risks resulting from capsule endoscopy are reported low and may include discomfort while swallowing, accidental aspiration and capsule retention leading to small bowel obstruction and perforation. the investigator will measure tolerability of capsule endoscopy as well as standard endoscopy using visual analogue scale.

Medtronic Spine LLC

Midwest Biomedical Research Foundation

Subject will swallow the OFDI capsule, marking will be performed by making superficial cautery marks on the tissue. This will be followed by imaging using the OFDI Imaging system.

Marking and imaging of the esophagus using the OFDI Capsule and system.

OFDI Capsule Marking

Guillermo Tearney, MD, PhD

The purpose of this research is to test the feasibility, sensitivity, and specificity of the marking Optical Frequency Domain Imaging (OFDI) capsule for diagnosing Barrett's Esophagus (BE).

A total of 130 subjects scheduled to undergo esophagogastroduodenoscopy (EGD) will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done.

OFDI real-time images will be used for targeting of the region to be marked. Once in position, two cautery marks will be made to only the superficial layers of the esophageal mucosa. Following cautery marking, the capsule will be lowered in the esophagus and marked regions of interest will be reimaged for confirmation of the placement of potential cautery marks.

Immediately following the completion of the experimental procedure, the standard of care with the performance of the surveillance endoscopy will be performed. Images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.

Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule

The images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Massachusetts General Hospital

Principal Investigator

Symptoms and General Pathology

Rare Diseases

Syndrome

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Stomach Diseases

Stomach Cancer

Diffuse Gastric Cancer

Hereditary Diffuse Gastric Cancer

Upper white-light endoscopy and confocal endoscopic microscopy

Patients will undergo white-light, upper endoscopy. In addition, during this endoscopy patients will undergo Confocal Endoscopic Microscopy (CEM) using the Cellvizio probe (Mauna Kea Technologies) to scan the same anatomic zones.

Endoscope+Cellvizio(R) 100 microscope

Jeremy L Davis, M.D.

Background:

People with hereditary gastric cancer syndrome are at increased risk of getting cancer in their stomach. These people should have regular endoscopies and biopsies to check for cancer if they are choosing to keep their stomach. Researchers want to see if they can improve the detection of cancer by endoscopy. Improved endoscopies could better detect early signs of cancer in people with this syndrome.

Objective:

To see if a small microscope attached to an endoscope to inspect the stomach lining is better than regular endoscopy to find the first signs of cancer in the stomach.

Eligibility:

People ages 18 and older who have a personal or family history of a hereditary gastric cancer syndrome or have a mutation that is known to lead to gastric cancer

Design:

Participants will be screened over the phone or in person with:

* Personal and family medical history
* Review of their medical records

Participants will have a physical exam. Then they will be put under general anesthesia. They will have an endoscopy. A lighted tube will be inserted into the mouth and go down to the stomach. First, the standard device will be used. Then participants will be injected with fluorescein. This is a contrast agent. Then the microscope will be added to the tube and the endoscopic evaluation of the stomach will be repeated. During the procedure, biopsies will be taken from different areas of the stomach. Participants will be observed for a few hours after the procedure.

About 14 days after the endoscopy, participants will be asked to return to the clinic for a follow-up visit. This visit can also be conducted over the phone.

Background:

Hereditary Diffuse Gastric Cancer (HDGC) syndrome is caused by a germline mutation in the Cadherin 1 (CDH1) gene. Carriers of this mutation have a 56-70% lifetime risk of developing gastric adenocarcinoma. Current international guidelines recommend endoscopic screening of CDH1 mutation carriers that consists of systematic biopsies of an otherwise normal appearing stomach. However, this approach lacks sufficient sensitivity for detecting intramucosal foci of signet ring cells (SRC), which are pathognomonic of HDGC syndrome. The goal of the current study is to utilize confocal endoscopic microscopy (CEM) for screening the gastric mucosa in this high-risk population.

Objective:

Determine if confocal endoscopic microscopy (CEM) will afford greater sensitivity for detection of signet ring cells (SRC) foci in CDH1 germline mutation carriers.

Eligibility:

CDH1 germline mutation carriers, or those who meet clinical criteria for HDGC testing but have tested negative for a CDH1 gene mutation or those who have other germline mutations suspected to be, or reported to be, associated with HDGC (e.g. Catenin Alpha 1 (CTNNA1).

Design:

Phase II, single-institution study of CEM for detection of intramucosal SRC foci compared to current systematic gastric mapping procedure.

Confocal Endoscopic Microscopy for Detection of Early Stage Gastric Cancer in Subjects With Hereditary Diffuse Gastric Cancer Syndrome

Phase II Study Evaluating Confocal Endoscopic Microscopy for Detection of Early Stage Gastric Cancer in Subjects With Hereditary Diffuse Gastric Cancer Syndrome

We will share the study protocol, statistical analysis plan, and clinical study report.

Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Sensitivity for detection of SRC foci in CDH1 germline mutation carriers was assessed by confocal endoscopic microscopy (CEM) compared to the current method of and standard white light endoscopy.

Sensitivity in CEM and WLE is defined as the percentage of participants with detectable cancer on endoscopic biopsy.

In participants who choose to undergo prophylactic total gastrectomy with permanent pathologic analysis, the false negative rate (the fraction of participants who have SRC foci not identified by CEM and White Light Endoscopy techniques) will be determined and reported. The fraction percentage of patients who underwent prophylactic total gastrectomy with findings of SRC foci in the gastrectomy specimen will represent the denominator (number) and the number of patients with negative findings by CEM and White Light Endoscopy (WLE) will represent the numerator (number) to generate the false negative detection rate (fraction) for CEM and WLE, respectively.

36/37 were evaluable for adverse events. One participant was determined to have Cadherin-1 (CDH1) variant of uncertain significance.

Upper white-light endoscopy and confocal endoscopic microscopy

Endoscope+Cellvizio(R) 100 microscope: Patients will undergo white-light, upper endoscopy. In addition, during this endoscopy patients will undergo Confocal Endoscopic Microscopy (CEM) using the Cellvizio probe (Mauna Kea Technologies) to scan the same anatomic zones.

1/Arm 1 - Upper White-light Endoscopy and Confocal Endoscopic Microscopy

Age, Categorical

Age, Continuous

Sex: Female, Male

Hispanic or Latino

Not Hispanic or Latino

Ethnicity Unknown or Not Reported

White

Race Other

Race Unknown

Race/Ethnicity, Customized

United States

Region of Enrollment

Dr. Jeremy L. Davis

White Light Endoscopy

36/37 were evaluable for this outcome measure. One participant was determined to have Cadherin-1 (CDH1) variant of uncertain significance.

Percentage of Participants With Detectable Confocal Endoscopic Microscopy (CEM) w/Greater Sensitivity for Detection of Signet Ring Cells (SRC)Foci in Cadherin-1 (CDH1) Germline Mutation Carriers Compared to Current Method of Standard White Light Endoscopy

Percentage of Participants Who Have Signet Ring Cells (SRC) Foci Not Identified by Confocal Endoscopic Microscopy (CEM)

Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Overall Study

IVLCM tethered capsule for obtaining biopsies for genomic sequencing of BE for the assessment of EAC risk.

Obtaining biopsies for genomic sequencing of BE for the assessment of EAC risk using IVLCM tethered capsule

IVLCM tethered capsule

Anita Chung, RN

Elizabeth Biddle, RN

Gary Tearney, MD., PhD

The investigators have developed a new technology, termed in-vivo laser capture microdissection (IVLCM), that addresses the limitations of endoscopic biopsy for screening for BE and provides targeted genomic profiling of aberrant tissue for more precise prediction of EAC risk. The device is a tethered capsule endomicroscope (TCE) that implements optical coherence tomography (OCT) to grab 10-mm-resolution, cross-sectional microscopic images of the entire esophagus after the capsule is swallowed. This OCT-based TCE technology is used in unsedated patients to visualize images of BE and dysplastic BE. During the IVLCM procedure, TCE images of abnormal BE tissue are identified in real time and selectively adhered onto the device. When the capsule is removed from the patient, these tissues, targeted based on their abnormal OCT morphology, are sent for genomic analysis. By enabling the precise isolation of aberrant esophageal tissues using a swallowable capsule, this technology has the potential to solve the major problems that currently prohibit adequate BE screening and prevention of Esophageal Adenocarcinoma EAC.

In Vivo Laser Capture Microdissection (IVLCM). The IVLCM tethered capsule is identical to those used in current approved OCT TCE studies.The capsule is swallowed by the patient and then, in real time, a region for tissue capture, is identified on the images. When a targeted site is identified, a capture laser (1450 nm, 0.8 W, 1 second exposure; within the range of the previously approved OCT-TCE tissue marking study) irradiates this area in the patient, heating the water in the tissue and transforming it to steam. The accumulated water steam overcomes the tissue matrix's adhesion force, ejecting a small amount of tissue and integrating it with the capsule's external shell. This process may then be repeated to collect multiple samples. After the device is pulled out from the patient, the captured tissues can be extracted for genomic analysis. Ex vivo animal tissue studies have shown that capture laser does not damage DNA/RNA; high quality whole genome information can be obtained.

In this IVLCM study, the investigators are using a 1450 nm laser to capture tissue that was previously approved to make cautery "marks" in the esophagus. The IVLCM capture laser's specifications are the same as those of the marking laser and the power will be within the IRB approved power range (0.82 W 1s). Prior to testing laser marking in humans, the investigators first demonstrated the safety of laser marking in animals in vivo. Histological assessment showed that the cautery marks did not penetrate through the submucosa and the vast majority of the effects were limited to the epithelium, lamina propria, and muscularis mucosa layers. The extent of thermal damage was comparable to conventional biopsies in standard of care endoscopic biopsy procedures. After this animal study, the investigators conducted a pilot study in humans in which over 30 marks were made in 22 enrolled subjects without any adverse events or safety concerns. In addition to these balloon studies, the investigators are currently conducting a TCE marking study. So far, the investigators have imaged and marked 13 subjects through a capsule without any adverse effects or safety concerns.

Thirty (N=30) subjects will be enrolled in this study.

Pilot Study for OCT Guided In Vivo Laser Capture Microdissection for Assessing the Prognosis of Barrett's Esophagus

We will measure the number of subjects from which we will be able to collect biopsy samples using IVLCM technique

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Performance Characteristics of Capsule Endoscopy With PillCam UGI Capsule Compared to Standard Endoscopy	NCT03167970	Barrett Esophag...	Pill cam EGD	18 Years - 85 Years	Midwest Veterans' Biomedical Research Foundation
Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule	NCT02422433	Barrett's Esoph...	OFDI Capsule Ma...	18 Years -	Massachusetts General Hospital
Confocal Endoscopic Microscopy for Detection of Early Stage Gastric Cancer in Subjects With Hereditary Diffuse Gastric Cancer Syndrome	NCT03648879	Gastric Cancer Gastric Neoplas...	Endoscope+Cellv...	18 Years -	National Institutes of Health Clinical Center (CC)
Pilot Study for OCT Guided In Vivo Laser Capture Microdissection for Assessing the Prognosis of Barrett's Esophagus	NCT03830801	Barrett Esophag...	IVLCM tethered ...	18 Years -	Massachusetts General Hospital
Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule	NCT02422433	Barrett's Esoph...	OFDI Capsule Ma...	18 Years -	Massachusetts General Hospital
Evaluation of Performance Characteristics of Capsule Endoscopy With PillCam UGI Capsule Compared to Standard Endoscopy	NCT03167970	Barrett Esophag...	Pill cam EGD	18 Years - 85 Years	Midwest Veterans' Biomedical Research Foundation
Pilot Study for OCT Guided In Vivo Laser Capture Microdissection for Assessing the Prognosis of Barrett's Esophagus	NCT03830801	Barrett Esophag...	IVLCM tethered ...	18 Years -	Massachusetts General Hospital

Spots Global Cancer Trial Database for egd

Every month we try and update this database with for egd 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 egd

Every month we try and update this database with for egd 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 egd 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.