Advanced Gastrointestinal Endoscopic Imaging
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|ClinicalTrials.gov Identifier: NCT01034670|
Recruitment Status : Suspended (Device not ready)
First Posted : December 17, 2009
Last Update Posted : December 6, 2016
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Advanced Gastrointestinal Endoscopic Imaging|
|Study Start Date :||June 2009|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
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: StanfordDevice: 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: OlympusDevice: CellVizio
Minimicroscope--this is an FDA approved fiber-based microscope that we will use according to the manufacturers protocols.
Other Name: Mauna Kea TechnologiesDrug: fluorescent Peptide
microdosing; Topical through the endoscope
Other Name: GMPDrug: fluorescein
100 mcg topical
Other Name: fluorophoreDrug: indocyanine green
100 mcg topical
Other Name: ICG
- Detection of neoplasia [ Time Frame: 5 years ]
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
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Shai Friedland||Stanford University|