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Advanced Gastrointestinal Endoscopic Imaging

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ClinicalTrials.gov Identifier: NCT01034670
Recruitment Status : Recruiting
First Posted : December 17, 2009
Last Update Posted : May 13, 2022
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Stanford University

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

Condition or disease Intervention/treatment Phase
Gastrointestinal Diseases Gastric (Stomach) Cancer Gastrointestinal Stromal Tumor (GIST) Device: Dual axis endoscopic microscope Device: wide field fluorescence system Device: CellVizio Drug: fluorescent Peptide Drug: fluorescein Drug: indocyanine green Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Advanced Gastrointestinal Endoscopic Imaging
Study Start Date : June 2009
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2025

Arm Intervention/treatment
Experimental: endoscopy arm
imaging performed in conjunction with the regularly scheduled endoscopy during which the newer imaging techniques will be used to detect premalignant conditions. includes wide field fluorescence, microscopy, Raman spectroscopy and/or ultrasound.
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.
Other Name: Stanford

Device: 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.
Other Name: Olympus

Device: CellVizio
Minimicroscope--this is an FDA approved fiber-based microscope that we will use according to the manufacturers protocols.
Other Name: Mauna Kea Technologies

Drug: fluorescent Peptide
microdosing; Topical through the endoscope
Other Name: GMP

Drug: fluorescein
100 mcg topical
Other Name: fluorophore

Drug: indocyanine green
100 mcg topical
Other Name: ICG

Primary Outcome Measures :
  1. Detection of neoplasia [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034670

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Contact: Cancer Clinical Trials Office (650) 498-7061 ccto-office@stanford.edu

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United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Cancer Clinical Trials Office, MD    650-498-7061    ccto-office@stanford.edu   
Sub-Investigator: Christopher H Contag         
Sub-Investigator: Jacques Van Dam M.D., Ph.D.         
Principal Investigator: Shai Friedland         
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
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Principal Investigator: Shai Friedland Stanford University
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01034670    
Other Study ID Numbers: IRB-15766
NCI-2021-03446 ( Other Identifier: NCI Trial Identifier )
U54CA136465 ( U.S. NIH Grant/Contract )
First Posted: December 17, 2009    Key Record Dates
Last Update Posted: May 13, 2022
Last Verified: May 2022
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Stomach Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Stomach Diseases