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NCT01034670 Clinical Trial

Advanced Gastrointestinal Endoscopic Imaging

Gastrointestinal Diseases Clinical Trial

Official title:
Advanced Gastrointestinal Endoscopic Imaging

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01034670
Other study ID # IRB-15766
Secondary ID NCI-2021-03446U5
Status Recruiting
Phase N/A
First received
Last updated
Start date June 2009
Est. completion date December 2025

Study information
Verified date February 2024
Source Stanford University
Contact Cancer Clinical Trials Office
Phone (650) 498-7061
Email ccto-office@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To develop new methods to detect malignant and premalignant conditions of the gastrointestinal tract.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date December 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:patients be at least 18 years of age, Either genders All ethnic backgrounds will be considered. Patients who are scheduled for endoscopy by one of the investigators will be asked if they are interested in participating in the study. The study will be open to all patients undergoing endoscopy that do not have exclusion criteria. We will ask all patients if they are participating in any other studies. If they are participating in any other study then we will ask them for more information to determine whether there could be any harm from participating in both studies and if there is then they will not be enrolled. Exclusion Criteria:Patients with unstable vital signs will not be included.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Dual axis endoscopic microscope
This is a device that is used in the accessory port of a standard endoscope and allows visualization of microscopic areas of mucosa.
• wide field fluorescence system
This is a modification to the existing narrow band endoscope from Olympus that incorporates different filters on the source and collecting optics to enable fluorescence imaging. It is used as is a standard endoscope.
• CellVizio
Minimicroscope--this is an FDA approved fiber-based microscope that we will use according to the manufacturers protocols.
Drug:
• fluorescent Peptide
microdosing; Topical through the endoscope
• fluorescein
100 mcg topical
• indocyanine green
100 mcg topical

Locations
Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (3)
Lead Sponsor Collaborator
Stanford University National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Detection of neoplasia 5 years
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