Evaluate the Use of Optical Frequency Domain Imaging (OFDI) for Celiac Disease in Children, Adolescents and Young Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study to Evaluate Use of Optical Frequency Domain Imaging (OFDI) for Duodenal Imaging in Celiac Disease in Children, Adolescents and Young Adults

Conditions
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Celiac Disease

Intervention / Treatment
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* Device: MGH OFDI Imaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MGH OFDI imaging<br>OFDI imaging | Device: MGH OFDI Imaging<br>* Imaging of Duodenum with OFDI system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | during imaging session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Celiac Disease, Duodenal, OCT, Imaging