Gastric In Vivo Study

April 28, 2017 updated by: Susana Gonzalez

Endoscopic Multispectral Imaging for the Early Detection of Gastric Neoplasia

The overall objective of this pilot study is to determine whether multispectral imaging increases the diagnostic accuracy of the current standard of high-definition white-light endoscopy for the detection of gastric neoplasia (high grade dysplasia or cancer). As part of an NCI-funded RO1, the investigators goal is to develop a multispectral endoscopic platform that can be used to survey a large surface area and, potentially, serve as a "red flag" for microendoscopic imaging of small areas. In prior ex vivo evaluations of surgical and endoscopic specimens, the investigators have identified the optical settings and illumination wavelengths that are complementary to white-light imaging and enhance superficial mucosal and vascular changes associated with neoplasia. Based on this initial testing, vital-dye enhanced fluorescence imaging (VFI) and imaging with High Resolution Microendoscope (HRME) have been identified as modalities that may be complementary to white-light imaging. The goal of this pilot study is to preliminarily determine the accuracy of these modalities during the endoscopic surveillance and detection of gastric neoplasia.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Consent will be obtained the day of the subject's scheduled endoscopy in a clinical room or at a routine office visit prior to the endoscopy. The study investigator will explain the study including the reasons why subject may be eligible, risks, and benefits. The subject will be given a chance to address any questions or concerns they may have.

If the patient agrees to participate in this study all of the procedures listed below will be performed the day of the scheduled endoscopy exam. The procedures listed are part of the routine standard of care for an endoscopy exam, except for the images that are being taken and the additional 2-6 biopsies taken from any abnormal areas that are seen with the new imaging technique. The use of the imaging technique described in this research study will not change the standard of care procedures.

The endoscopic procedure is outlined below:

  1. White Light Examination: Examination will initially be performed in the standard white-light endoscopic mode as is routinely done. Abnormal gastric mucosa areas and nodularities will be recorded. Any "Suspicious" areas (visible abnormalities, etc.) will be photographed and the location recorded (distance from incisors and endoscopic quadrant, eq. 34 cm; greater curvature, lesser curvature, etc).
  2. Vital-Dye Enhanced Fluorescence Examination: Following this, the stomach will be sprayed with 1-10 ml of 0.01% proflavine using a standard endoscopic spray-catheter. Using the fluorescent imaging, the location of any VFI-"Suspicious' areas will be recorded. Additionally, VFI examination of any suspicious areas seen on WLE will be performed. The endoscopist will label the surface-appearance of each WLE abnormal area based on its VFI appearance. Thus, each area will be labeled as: "Not Suspicious," or "Suspicious for Neoplasia."
  3. HRME examination: WLE and VFI suspicious appearing areas will be further imaged with HRME. HRME will be inserted through the biopsy channel of the endoscope, gently placed against the mucosa, and images of suspicious areas will be obtained. The endoscopist will label the surface-appearance of each WLE abnormal area and VFI abnormal area, based on the HRME appearance. Thus, each area will be labeled as: "Not Suspicious," or "Suspicious for Neoplasia."
  4. Biopsy Protocol: Biopsies will be obtained of any area suspicious on any of the imaging modalities (WLE, VFI or HRME). Additionally, two 'control' areas (normal on imaging) will also be biopsied. Lastly, routine, biopsies will be performed per clinical care to determine areas of intestinal metaplasia and H pylori infection as per routine standard of care.
  5. Pathologic Interpretation: All samples will be evaluated by a single expert gastrointestinal pathologist who will be blinded to the endoscopic findings

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • ICAHN School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with high grade dysplasia in the stomach and known or suspected cancer of the stomach undergoing endoscopic surveillance
  • at least 18 years of age

Exclusion Criteria:

  • subjects who report an allergy to Proflavine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surveillance Endoscopy
White light examination, vital-dye enhanced fluorescence examination (VFI), High Resolution Microendoscope (HRME)
Drug: Proflavine Hemisulphate salt
The stomach will be sprayed with 1-10 ml of 0.01% proflavine using a standard endoscopic spray-catheter.
Other Names:
  • Vital-dye enhanced fluorescence imaging
  • VFI
Procedure: White-light examination
standard white light examination
Other Names:
  • White-light endoscopic examination
Procedure: Imaging with High Resolution Microendoscope
HRME will be inserted through the biopsy channel of the endoscope, gently placed against the mucosa, and images of suspicious areas will be obtained.
Other Names:
  • HRME
  • VFI/HRME

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric neoplasia presence
Time Frame: Day 1
Comparison of the efficiency of widefield imaging modality or combination of modalities (WLE, WLE+VFI/HRME for the highest accuracy on the detection of gastric neoplasia
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity for the detection of neoplasia
Time Frame: Day 1
the potential errors in estimation of sensitivity (true positive rate)
Day 1
Specificity for the detection of neoplasia
Time Frame: Day 1
the potential errors in estimation of specificity (true negative rate)
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Susana Gonzalez

Collaborators

William Marsh Rice University

Investigators

  • Principal Investigator: Susana Gonzalez, MD, ICAHN School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 31, 2014

First Submitted That Met QC Criteria

August 1, 2014

First Posted (Estimate)

August 4, 2014

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

April 28, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 09-0696B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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