Advanced Gastrointestinal Endoscopic Imaging

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

Official Title
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Advanced Gastrointestinal Endoscopic Imaging

Conditions
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Gastrointestinal Diseases, Gastric (Stomach) Cancer, Gastrointestinal Stromal Tumor (GIST)

Intervention / Treatment
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* Device: Dual axis endoscopic microscope
* Device: wide field fluorescence system
* Device: CellVizio
* Drug: fluorescent Peptide
* Drug: fluorescein
* Drug: indocyanine green


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endoscopy arm<br>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<br>* This is a device that is used in the accessory port of a standard endoscope and allows visualization of microscopic areas of mucosa.<br>* Other names: Stanford;Device: wide field fluorescence system<br>* 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.<br>* Other names: Olympus;Device: CellVizio<br>* Minimicroscope--this is an FDA approved fiber-based microscope that we will use according to the manufacturers protocols.<br>* Other names: Mauna Kea Technologies;Drug: fluorescent Peptide<br>* microdosing; Topical through the endoscope<br>* Other names: GMP;Drug: fluorescein<br>* 100 mcg topical<br>* Other names: fluorophore;Drug: indocyanine green<br>* 100 mcg topical<br>* Other names: ICG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of neoplasia |  | 5 years |