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Advanced Gastrointestinal Endoscopic Imaging

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dual axis endoscopic microscope
wide field fluorescence system
CellVizio
fluorescent Peptide
fluorescein
indocyanine green
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastrointestinal Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

endoscopy arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Detection of neoplasia

Secondary Outcome Measures

Full Information

First Posted
November 13, 2009
Last Updated
May 17, 2023
Sponsor
Stanford University
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01034670
Brief Title
Advanced Gastrointestinal Endoscopic Imaging
Official Title
Advanced Gastrointestinal Endoscopic Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Diseases, Gastric (Stomach) Cancer, Gastrointestinal Stromal Tumor (GIST)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
endoscopy arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Dual axis endoscopic microscope
Other Intervention Name(s)
Stanford
Intervention Description
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
Intervention Name(s)
wide field fluorescence system
Other Intervention Name(s)
Olympus
Intervention Description
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
Intervention Name(s)
CellVizio
Other Intervention Name(s)
Mauna Kea Technologies
Intervention Description
Minimicroscope--this is an FDA approved fiber-based microscope that we will use according to the manufacturers protocols.
Intervention Type
Drug
Intervention Name(s)
fluorescent Peptide
Other Intervention Name(s)
GMP
Intervention Description
microdosing; Topical through the endoscope
Intervention Type
Drug
Intervention Name(s)
fluorescein
Other Intervention Name(s)
fluorophore
Intervention Description
100 mcg topical
Intervention Type
Drug
Intervention Name(s)
indocyanine green
Other Intervention Name(s)
ICG
Intervention Description
100 mcg topical
Primary Outcome Measure Information:
Title
Detection of neoplasia
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cancer Clinical Trials Office
Phone
(650) 498-7061
Email
ccto-office@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shai Friedland
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cancer Clinical Trials Office, MD
Phone
650-498-7061
Email
ccto-office@stanford.edu
First Name & Middle Initial & Last Name & Degree
Christopher H Contag
First Name & Middle Initial & Last Name & Degree
Jacques Van Dam M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Shai Friedland

12. IPD Sharing Statement

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Advanced Gastrointestinal Endoscopic Imaging

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