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Gastric In Vivo Study

NCT02207959 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2017-05-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Proflavine Hemisulphate salt

The stomach will be sprayed with 1-10 ml of 0.01% proflavine using a standard endoscopic spray-catheter.

PROCEDURE

White-light examination

standard white light 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.

Sponsors & Collaborators

  • William Marsh Rice University

    collaborator OTHER

  • Susana Gonzalez

    lead OTHER

Principal Investigators

  • Susana Gonzalez, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02207959 on ClinicalTrials.gov