NCT01384227

Brief Summary

The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of barrett's esophagus in vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is a pilot study of an novel technology, a miniaturized microscope device which can be used during upper endoscopy to image the gastrointestinal epithelium. This is an exploratory, not a comparative, study designed to evaluate the feasibility of using this instrument in Barrett's esophagus.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 29, 2011

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

2.4 years

First QC Date

June 21, 2011

Last Update Submit

January 8, 2016

Conditions

Barrett's Esophagus

Keywords

Barrett's esophagusin vivo imagingimage guide microscope

Outcome Measures

Primary Outcomes (1)

  • To determine whether tissue is neoplastic or non-neoplastic

    1 day

Study Arms (1)

Proflavine Hemisulfate

EXPERIMENTAL
Drug: Proflavine Hemisulfate

Interventions

Proflavine HemisulfateDRUG

Proflavine hemisulfate 0.01% (derived from dissolving 10 mg Proflavine Hemisulfate USP in 100 ml of sterile water)

Also known as: Proflavine
Proflavine Hemisulfate

Eligibility Criteria

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

You may qualify if:

  • Barrett's without dysplasia
  • Barrett's with dysplasia
  • Esophageal Adenocarcinoma

You may not qualify if:

  • Subjects unfit for standard upper endoscopy
  • Subjects currently receiving chemo or radiation treatment
  • Subject currently receiving PDT or ablation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Related Publications (1)

  • Shin D, Lee MH, Polydorides AD, Pierce MC, Vila PM, Parikh ND, Rosen DG, Anandasabapathy S, Richards-Kortum RR. Quantitative analysis of high-resolution microendoscopic images for diagnosis of neoplasia in patients with Barrett's esophagus. Gastrointest Endosc. 2016 Jan;83(1):107-14. doi: 10.1016/j.gie.2015.06.045. Epub 2015 Aug 5.

    PMID: 26253018DERIVED

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Proflavine

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

AminoacridinesAcridinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Sharmila Anandasabapathy

    Mt. Sinai School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicne

Study Record Dates

First Submitted

June 21, 2011

First Posted

June 29, 2011

Study Start

February 1, 2009

Primary Completion

July 1, 2011

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations

US(1)