Advanced Gastrointestinal Endoscopic Imaging

NCT ID: NCT01034670

Last Updated: 2024-06-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2017-09-25

Brief Summary

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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Dual axis endoscopic microscope

Intervention Type DEVICE

This is a device that is used in the accessory port of a standard endoscope and allows visualization of microscopic areas of mucosa.

wide field fluorescence system

Intervention Type DEVICE

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.

CellVizio

Intervention Type DEVICE

Minimicroscope--this is an FDA approved fiber-based microscope that we will use according to the manufacturers protocols.

fluorescent Peptide

Intervention Type DRUG

microdosing; Topical through the endoscope

fluorescein

Intervention Type DRUG

100 mcg topical

indocyanine green

Intervention Type DRUG

100 mcg topical

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

CellVizio

Minimicroscope--this is an FDA approved fiber-based microscope that we will use according to the manufacturers protocols.

Intervention Type DEVICE

fluorescent Peptide

microdosing; Topical through the endoscope

Intervention Type DRUG

fluorescein

100 mcg topical

Intervention Type DRUG

indocyanine green

100 mcg topical

Intervention Type DRUG

Other Intervention Names

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Stanford Olympus Mauna Kea Technologies GMP fluorophore ICG

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shai Friedland

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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NCI-2021-03446

Identifier Type: OTHER

Identifier Source: secondary_id

U54CA136465

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-15766

Identifier Type: -

Identifier Source: org_study_id

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