Advanced Gastrointestinal Endoscopic Imaging
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Stanford University
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Number of Participants With Successful Imaging of the Mucosa
Study Overview
Brief Summary
To develop new methods to detect malignant and premalignant conditions of the gastrointestinal tract.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Dual axis endoscopic microscope (Device)
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.
Intervention: wide field fluorescence system (Device)
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.
Intervention: CellVizio (Device)
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.
Intervention: fluorescent Peptide (Drug)
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.
Intervention: fluorescein (Drug)
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.
Intervention: indocyanine green (Drug)
Outcomes
Primary Outcomes
Number of Participants With Successful Imaging of the Mucosa
Time Frame: 5 years
Detection of mucosa abnormailities as a first step in the goal of detection of neoplasia
Secondary Outcomes
No secondary outcomes reported