Barrett's Esophagus
Conditions
Keywords
Barrett's Esophagus, Esophagus, OCT, Imaging
Brief summary
The specific aim of this study is to determine the feasibility of marking target pathologic locations identified on Optical Frequency Domain Imaging (OFDI) datasets using superficial cautery marks of the esophagus that are visible by endoscopy for subsequent guidance of biopsy.
Detailed description
Twenty four consenting patients undergoing esophagogastroduodenoscopy (EGD) surveillance following a confirmed diagnosis of Barrett's esophagus will be recruited at Massachusetts General Hospital (MGH) . Along with Optical Frequency Domain Imaging (OFDI) imaging and cautery marking for targeted biopsy, the patients will undergo a standard of care clinical Esophagogastroduodenoscopy (EGD) procedure including endoscopic random biopsy. This study requires the use of a balloon catheter which is a commonly used technique and is accepted in clinical practice for dilation of esophageal and colonic strictures and for photodynamic therapy. Once in position, the OFDI tissue marking laser will be activated by the physician. The physician will control the marking and make two marks of a duration of 2 seconds each. The 2 seconds time period will limit the tissue effects to only the superficial layers of the esophageal mucosa. It is expected that the total experimental time including insertion and inflation of the OFDI balloon catheter, OFDI imaging, tissue marking, and removal of the OFDI balloon will add approximately 15 minutes to the total length of the EGD.
Interventions
DEVICEMGH OFDI marking
Imaging of esophagus with OFDI system
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Massachusetts General Hospital
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 undergoing an EGD for Barrett's esophagus surveillance with a prior confirmed Barrett's segment at least 1 cm in length * Patients must be over the age of 18 * Patient must be able to give informed consent * Women with child bearing potential must have a negative pregnancy test prior to procedure
Exclusion criteria
* Patients on anti-platelet and anti-coagulation medications and NSAIDS at the time of procedure * Patients with a history of hemostasis disorders * Patients that are pregnant * Patients with esophageal strictures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects in Which the Targeted Locations Identified Through OFDI Imaging Correlates With the Biopsies. | day 1, during diagnostic procedure | Determination of the feasibility to mark targeted pathologic locations identified through OFDI imaging using superficial cautery marks.Verification by endoscopy and utilization of the marks for biopsy guidance.Images will be analyzed and compared to biopsies of the correlated marked tissue. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MGH OFDI Marking and Imaging OFDI imaging
MGH OFDI marking: Imaging of esophagus with OFDI system | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | MGH OFDI Marking and Imaging |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 14 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 64 years STANDARD_DEVIATION 11.84 |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 22 |
| other Total, other adverse events | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
Number of Subjects in Which the Targeted Locations Identified Through OFDI Imaging Correlates With the Biopsies.
Determination of the feasibility to mark targeted pathologic locations identified through OFDI imaging using superficial cautery marks.Verification by endoscopy and utilization of the marks for biopsy guidance.Images will be analyzed and compared to biopsies of the correlated marked tissue.
Time frame: day 1, during diagnostic procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MGH OFDI Marking and Imaging | Number of Subjects in Which the Targeted Locations Identified Through OFDI Imaging Correlates With the Biopsies. | 22 Participants |