NCT02207959

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1 gastric-cancer

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_1 gastric-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

May 2, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

July 31, 2014

Last Update Submit

April 28, 2017

Conditions

Gastric Cancer

Keywords

Gastric cancerNeoplasiaEndoscopic imagingIn vivo imaging

Outcome Measures

Primary Outcomes (1)

  • Gastric neoplasia presence

    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 Outcomes (2)

  • Sensitivity for the detection of neoplasia

    Day 1

  • Specificity for the detection of neoplasia

    Day 1

Study Arms (1)

Surveillance Endoscopy

EXPERIMENTAL

White light examination, vital-dye enhanced fluorescence examination (VFI), High Resolution Microendoscope (HRME)

Drug: Proflavine Hemisulphate saltProcedure: White-light examinationProcedure: Imaging with High Resolution Microendoscope

Interventions

Proflavine Hemisulphate saltDRUG

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

Also known as: Vital-dye enhanced fluorescence imaging, VFI
Surveillance Endoscopy
White-light examinationPROCEDURE

standard white light examination

Also known as: White-light endoscopic examination
Surveillance Endoscopy
Imaging with High Resolution MicroendoscopePROCEDURE

HRME will be inserted through the biopsy channel of the endoscope, gently placed against the mucosa, and images of suspicious areas will be obtained.

Also known as: HRME, VFI/HRME
Surveillance Endoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • subjects who report an allergy to Proflavine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Stomach NeoplasmsNeoplasms

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Susana Gonzalez, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 31, 2014

First Posted

August 4, 2014

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

May 2, 2017

Record last verified: 2017-04

Locations

US(1)