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In Vivo nCLE Study in the Pancreas With Endosonography of Cystic Tumors


N/A
18 Years
N/A
Not Enrolling
Both
Pancreatic Cysts

Thank you

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