Back to resultsEvaluation of a Miniaturized Microscope Device for the Detection of Esophageal Squamous Cell Cancer
Primary Purpose
Squamous Cell Cancer
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
proflavine
Sponsored by
About this trial
This is an interventional screening trial for Squamous Cell Cancer focused on measuring squamous cell cancer, squamous cell neoplasia
Eligibility Criteria
Inclusion Criteria:
- known or suspected squamous cell neoplasia
- 18 years or older
Sites / Locations
- Mount Sinai Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment
Arm Description
imaging with proflavine
Outcomes
Primary Outcome Measures
to determine whether or not tissue is neoplastic or non-neoplastic
Secondary Outcome Measures
Full Information
NCT ID
NCT01384708
First Posted
June 28, 2011
Last Updated
January 7, 2016
Sponsor
Anandasabapathy, Sharmila, M.D.
Collaborators
William Marsh Rice University
1. Study Identification
Unique Protocol Identification Number
NCT01384708
Brief Title
Evaluation of a Miniaturized Microscope Device for the Detection of Esophageal Squamous Cell Cancer
Official Title
Evaluation of a Miniaturized Microscope Device for the Detection of Esophageal Squamous Cell Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anandasabapathy, Sharmila, M.D.
Collaborators
William Marsh Rice University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Cancer
Keywords
squamous cell cancer, squamous cell neoplasia
7. Study Design
Primary Purpose
Screening
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment
Arm Type
Experimental
Arm Description
imaging with proflavine
Intervention Type
Drug
Intervention Name(s)
proflavine
Other Intervention Name(s)
Proflavine hemisulfate
Intervention Description
1-10 ml of proflavine (derived form dissolving 10mg proflavine hemisulfate USP in 100 ml sterile water)
Primary Outcome Measure Information:
Title
to determine whether or not tissue is neoplastic or non-neoplastic
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
known or suspected squamous cell neoplasia
18 years or older
Facility Information:
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25980753
Citation
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.
Results Reference
derived
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Evaluation of a Miniaturized Microscope Device for the Detection of Esophageal Squamous Cell Cancer
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