NCT01384864

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 Barrett's-associated neoplasia (high grade dysplasia or cancer). 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. The goal of this pilot study is to preliminarily determine the accuracy of these modalities during the endoscopic surveillance of Barrett's esophagus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Aug 2011

Longer than 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

First Submitted

Initial submission to the registry

June 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 11, 2016

Status Verified

January 1, 2016

Enrollment Period

4.3 years

First QC Date

June 28, 2011

Last Update Submit

January 7, 2016

Conditions

Barrett's EsophagusIntraepithelial Neoplasia

Keywords

barrett's esophagusintraepithelial neoplasiacross polarized reflectance examinationvital-dye enhanced fluorescence examination

Outcome Measures

Primary Outcomes (1)

  • to determine whether tissue is neoplastic or non-neoplastic

    1 day

Study Arms (1)

treatment

EXPERIMENTAL

fluorescent imaging with proflavine

Drug: proflavine

Interventions

proflavineDRUG

2-6 ml of 0.01% proflavine

Also known as: Proflavine hemisulfate
treatment

Eligibility Criteria

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

You may qualify if:

  • years or older
  • known or suspected barrett's esophagus with intraepithelial neoplasia(HGD/cancer)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Barrett EsophagusCarcinoma in Situ

Interventions

Proflavine

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2011

First Posted

June 29, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 11, 2016

Record last verified: 2016-01

Locations

US(1)