Evaluate the Use of Optical Frequency Domain Imaging (OFDI) for Celiac Disease in Children, Adolescents and Young Adults
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MGH OFDI imaging OFDI imaging |
Device: MGH OFDI Imaging
Imaging of Duodenum with OFDI system
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
Investigators
- Principal Investigator: Guillermo Tearney, MD PhD, Massachusetts General Hospital
- Principal Investigator: Aubrey Katz, MD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2009-P-000938
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | MGH OFDI Imaging |
|---|---|
| Arm/Group Description | OFDI imaging MGH OFDI Imaging: Imaging of Duodenum with OFDI system |
| Period Title: Overall Study | |
| STARTED | 6 |
| COMPLETED | 6 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | MGH OFDI Imaging |
|---|---|
| Arm/Group Description | OFDI imaging MGH OFDI Imaging: Imaging of Duodenum with OFDI system |
| Overall Participants | 6 |
| Age (Count of Participants) | |
| <=18 years |
4
66.7%
|
| Between 18 and 65 years |
2
33.3%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
16.3
(5)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
4
66.7%
|
| Male |
2
33.3%
|
| Region of Enrollment (Count of Participants) | |
| United States |
6
100%
|
Outcome Measures
| Title | Number of Subjects With Changes of Villous Architecture Undergoing OFDI Imaging |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects 7 or over 7 years old with Celiac Disease |
| Arm/Group Title | Compare OFDI Images to Histologic |
|---|---|
| Arm/Group Description | compare OFDI images to histologic evaluation in children, adolescents and young adults with suspected Celiac disease |
| Measure Participants | 6 |
| Count of Participants [Participants] |
6
100%
|
Adverse Events
| Time Frame | The duration of the imaging procedure | |
|---|---|---|
| Adverse Event Reporting Description | No adverse evens has been reported | |
| Arm/Group Title | MGH OFDI Imaging | |
| Arm/Group Description | OFDI imaging MGH OFDI Imaging: Imaging of Duodenum with OFDI system | |
All Cause Mortality |
||
| MGH OFDI Imaging | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/6 (0%) | |
Serious Adverse Events |
||
| MGH OFDI Imaging | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/6 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| MGH OFDI Imaging | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/6 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Gary Tearney PI |
|---|---|
| Organization | Massachusetts General Hospital |
| Phone | 617-724-2979 |
| gtearney@partners.org |
- 2009-P-000938