In Vivo nCLE Study in the Pancreas With Endosonography of Cystic Tumors
18 Years
N/A
Both
Pancreatic Cysts
Trial Information
In Vivo nCLE Study in the Pancreas With Endosonography of Cystic Tumors
The primary aim of the study is to define interpretation criteria to differentiate mucinous
from non-mucinous cysts and classify more precisely the cysts. Once these criteria have been
defined, the diagnostic parameters of nCLE in differentiating the different types of cysts
and the reproducibility of these criteria will be assessed.
Inclusion Criteria:
- Patients scheduled for an EUSFNA procedure of a pancreatic cyst,
- Patients aged 18 years or older,
- Patients is under surgical consideration for management of the cyst
- Patients have provided written informed consent for the study
Exclusion Criteria:
- Allergy to fluorescein
- Pregnancy or breast-feeding
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Image interpretation criteria
Outcome Description:
The primary aim of the INSPECT study is to define descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts, and then to identify those criteria which have the best diagnostic accuracy retrospectively
Outcome Time Frame:
October 2011
Safety Issue:
No
Principal Investigator
Irving Waxman, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Chicago
Authority:
United States: Food and Drug Administration
Study ID:
MKT-2010-INSPECT
NCT ID:
NCT01236300
Start Date:
July 2010
Completion Date:
May 2012
Related Keywords:
- Pancreatic Cysts
- Pancreatic cysts
- Pancreatic Cyst
Name | Location |
|---|---|
| Mayo Clinic Jacksonville | Jacksonville, Florida 32224 |
| University of Washington | Seattle, Washington 98195 |
| Yale University | New Haven, Connecticut 06520 |
| University of Chicago | Chicago, Illinois 60637 |
| University of California Irvine | Irvine, California 92697 |
| Cedar Sinaï Medical Center | Los Angeles, California CA90048 |
