Gastrointestinal Diseases, Gastric (Stomach) Cancer, Gastrointestinal Stromal Tumor (GIST)
Conditions
Brief summary
To develop new methods to detect malignant and premalignant conditions of the gastrointestinal tract.
Interventions
DRUGfluorescent Peptide
microdosing; Topical through the endoscope
DRUGfluorescein
100 mcg topical
DRUGindocyanine green
100 mcg topical
DEVICEDual 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.
DEVICEwide 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.
DEVICECellVizio
Minimicroscope--this is an FDA approved fiber-based microscope that we will use according to the manufacturers protocols.
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Imaging of the Mucosa | 5 years | Detection of mucosa abnormailities as a first step in the goal of detection of neoplasia |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | Endoscopy Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 3 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Number of Participants With Successful Imaging of the Mucosa
Detection of mucosa abnormailities as a first step in the goal of detection of neoplasia
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endoscopy Arm | Number of Participants With Successful Imaging of the Mucosa | 3 Participants |