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Advanced Gastrointestinal Endoscopic Imaging

This study has suspended participant recruitment.
(Device not ready)
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01034670
First received: November 13, 2009
Last updated: February 17, 2011
Last verified: February 2011
History of Changes
  Purpose

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


Condition Intervention
Gastrointestinal Diseases
Malignant Neoplasm of Stomach
Gastrointestinal Stromal Tumors
 Device: Dual axis endoscopic microscope
Device: wide field fluorescence system
Device: CellVizio
Drug: fluorescent Peptide
Drug: fluorescein
Drug: indocyanine green

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Advanced Gastrointestinal Endoscopic Imaging

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Detection of neoplasia [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: June 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034670

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Shai Friedland Stanford University
  More Information

No publications provided

Responsible Party: Shai Friedland, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01034670     History of Changes
Other Study ID Numbers: SU-06302009-2800, GIIMG0002, 5U54CA105296-03
Study First Received: November 13, 2009
Last Updated: February 17, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Stomach Neoplasms
Gastrointestinal Stromal Tumors
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Stomach Diseases

ClinicalTrials.gov processed this record on May 19, 2013