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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 (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01034670
First received: November 13, 2009
Last updated: December 5, 2016
Last verified: December 2016
  Purpose
To develop new methods to detect malignant and premalignant conditions of the gastrointestinal tract.

Condition Intervention
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

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

Resource links provided by NLM:


Further study details as provided by Stanford University:

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

Estimated Enrollment: 500
Study Start Date: June 2009
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01034670     History of Changes
Other Study ID Numbers: GIIMG0002  5U54CA105296-03  IRB-15766 
Study First Received: November 13, 2009
Last Updated: December 5, 2016

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Gastrointestinal Diseases
Digestive System Diseases
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms

ClinicalTrials.gov processed this record on February 24, 2017