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Advanced Gastrointestinal Endoscopic Imaging

Sponsor
Stanford University (Other)
Overall Status
Recruiting
CT.gov ID
NCT01034670
Collaborator
National Institutes of Health (NIH) (NIH)
500
Enrollment
1
Location
1
Arm
198
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Dual axis endoscopic microscope
  • Device: wide field fluorescence system
  • Device: CellVizio
  • Drug: fluorescent Peptide
  • Drug: fluorescein
  • Drug: indocyanine green
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Jun 1, 2009
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

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 Names:
  • 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 Names:
  • Olympus

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

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

    • Drug: fluorescein
    100 mcg topical
    Other Names:
  • fluorophore

    • Drug: indocyanine green
    100 mcg topical
    Other Names:
  • ICG

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Detection of neoplasia [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University School of Medicine Stanford California United States 94305

    Sponsors and Collaborators

    • Stanford University
    • National Institutes of Health (NIH)

    Investigators

    • Principal Investigator: Shai Friedland, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stanford University
    ClinicalTrials.gov Identifier:
    NCT01034670
    Other Study ID Numbers:
    • IRB-15766
    • NCI-2021-03446
    • U54CA136465
    First Posted:
    Dec 17, 2009
    Last Update Posted:
    May 13, 2022
    Last Verified:
    May 1, 2022
    Additional relevant MeSH terms:
    Gastrointestinal Stromal Tumors
    Stomach Neoplasms
    Gastrointestinal Diseases
    Digestive System Diseases

    Study Results

    No Results Posted as of May 13, 2022