Advanced Gastrointestinal Endoscopic Imaging

NCT01034670 | Terminated Results DMC

• 3 other identifiers: IRB-15766NCI-2021-03446U54CA136465
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Successful Imaging of the Mucosa

  Detection of mucosa abnormailities as a first step in the goal of detection of neoplasia

  5 years

Study Arms (1)

endoscopy arm

EXPERIMENTAL

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; Device: wide field fluorescence system; Device: CellVizio; Drug: fluorescent Peptide; Drug: fluorescein; Drug: indocyanine green

Interventions

Dual axis endoscopic microscope DEVICE

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

Also known as: Stanford

endoscopy arm

wide field fluorescence system 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.

Also known as: Olympus

endoscopy arm

CellVizio DEVICE

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

Also known as: Mauna Kea Technologies

endoscopy arm

fluorescent Peptide DRUG

microdosing; Topical through the endoscope

Also known as: GMP

endoscopy arm

fluorescein DRUG

100 mcg topical

Also known as: fluorophore

endoscopy arm

indocyanine green DRUG

100 mcg topical

Also known as: ICG

endoscopy arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Gastrointestinal Diseases; Stomach Neoplasms; Gastrointestinal Stromal Tumors

Interventions

Fluorescein; Indocyanine Green

Condition Hierarchy (Ancestors)

Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Stomach Diseases; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring

Results Point of Contact

• Title: Shai Friedland, MD
• Organization: Stanford University

shaif@stanford.edu

(650) 617-2732

Study Officials

• Shai Friedland

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2009
• First Posted: December 17, 2009
• Study Start: June 1, 2009
• Primary Completion: September 25, 2017
• Study Completion: September 25, 2017
• Last Updated: June 26, 2024
• Results First Posted: June 26, 2024

Record last verified: 2024-05

Locations

US (1)