Celiac Disease
Conditions
Keywords
Celiac Disease, Duodenal, OCT, Imaging
Brief summary
The goal of this research is to conduct a pilot clinical study to image Celiac disease characteristic mucosal lesions and compare Optical Frequency Domain Imaging (OFDI) images to histologic evaluation in children, adolescents and young adults with suspected Celiac disease.
Detailed description
The Optical Frequency Domain Imaging(OFDI) catheter will be used in conjunction with a standard pediatric endoscope. The endoscopist will introduce the OFDI imaging catheter through the biopsy channel of the endoscope already in place. The catheter will be passed into the view of the endoscope so that the tip of the catheter can be directly visualized throughout the procedure. The catheter will be placed adjacent to the bowel wall in the vicinity of the target locations. Once the OFDI probe is in place, OFDI imaging will start and data will be continuously collected during helical pullback scanning of the inner catheter drive shaft over a predetermined length of approximately 3 cm. It is expected that the total experimental procedure including the insertion of the OFDI catheter, OFDI imaging, and removal of the catheter will add approximately 10 minutes to the total length of the procedure.
Interventions
DEVICEMGH OFDI Imaging
Imaging of Duodenum with OFDI system
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 7 years and above undergoing upper endoscopy for evaluation of celiac disease * Clinical history, physical findings, family history, or serologic evaluation suggestive of celiac disease * Parents/guardian available to sign informed consent
Exclusion criteria
* Patients with a history of hemostasis disorders * Use of Nonsteroidal anti-inflammatory drugs(NSAIDS) within ten days preceding initiation of the study * Use of any oral anticoagulation medication within one month preceding initiation of the study * Any known blood coagulation disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Changes of Villous Architecture Undergoing OFDI Imaging | during imaging session | OFDI images analyzed and compared to standard of care biopsies to identify celiac disease caracteristic mucosal lesions. In this pilot study, we demonstrated the feasibility of using OFDI for visualizing changes of villous architecture in CD patients in vivo |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MGH OFDI Imaging OFDI imaging
MGH OFDI Imaging: Imaging of Duodenum with OFDI system | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | MGH OFDI Imaging |
|---|---|
| Age, Categorical <=18 years | 4 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 16.3 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 6 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Number of Subjects With Changes of Villous Architecture Undergoing OFDI Imaging
OFDI images analyzed and compared to standard of care biopsies to identify celiac disease caracteristic mucosal lesions. In this pilot study, we demonstrated the feasibility of using OFDI for visualizing changes of villous architecture in CD patients in vivo
Time frame: during imaging session
Population: Subjects 7 or over 7 years old with Celiac Disease
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compare OFDI Images to Histologic | Number of Subjects With Changes of Villous Architecture Undergoing OFDI Imaging | 6 Participants |