NCT01384708

Brief Summary

The overall objective of this study is to determine whether high-resolution imaging of the esophagus during routine diagnostic upper endoscopy can assist clinicians in detecting and discriminating dysplastic (precancerous) areas. This high-resolution microendoscope (HRME) was developed by our collaborators at Rice University and provides \> 1000x magnified images of the esophageal mucosa. The purpose of this study is to determine whether this device can be used to enhance the diagnostic accuracy of routine endoscopic screening for squamous cell cancer of the esophagus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Aug 2010

Typical duration 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

August 1, 2010

Completed
11 months until next milestone

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
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

January 11, 2016

Status Verified

March 1, 2014

Enrollment Period

3.2 years

First QC Date

June 28, 2011

Last Update Submit

January 7, 2016

Conditions

Squamous Cell Cancer

Keywords

squamous cell cancersquamous cell neoplasia

Outcome Measures

Primary Outcomes (1)

  • to determine whether or not tissue is neoplastic or non-neoplastic

    1 day

Study Arms (1)

treatment

EXPERIMENTAL

imaging with proflavine

Drug: proflavine

Interventions

proflavineDRUG

1-10 ml of proflavine (derived form dissolving 10mg proflavine hemisulfate USP in 100 ml sterile water)

Also known as: Proflavine hemisulfate
treatment

Eligibility Criteria

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

You may qualify if:

  • known or suspected squamous cell neoplasia
  • years or older

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)

  • Protano MA, Xu H, Wang G, Polydorides AD, Dawsey SM, Cui J, Xue L, Zhang F, Quang T, Pierce MC, Shin D, Schwarz RA, Bhutani MS, Lee M, Parikh N, Hur C, Xu W, Moshier E, Godbold J, Mitcham J, Hudson C, Richards-Kortum RR, Anandasabapathy S. Low-Cost High-Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia: An International Trial. Gastroenterology. 2015 Aug;149(2):321-329. doi: 10.1053/j.gastro.2015.04.055. Epub 2015 May 14.

    PMID: 25980753DERIVED

MeSH Terms

Conditions

Neoplasms, Squamous Cell

Interventions

Proflavine

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

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, 2010

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

January 11, 2016

Record last verified: 2014-03

Locations

US(1)