In Vivo nCLE Study in the Pancreas With Endosonography of Cystic Tumors (INSPECT)
This study has been completed.
Sponsor:
University of Chicago
Collaborators:
Mauna Kea Technologies
Institut Paoli-Calmettes
Technische Universität München
Yale University
University of California, Irvine
Mayo Clinic
University of Washington
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Vani Konda, University of Chicago
ClinicalTrials.gov Identifier:
NCT01236300
First received: November 5, 2010
Last updated: January 14, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Assess the safety and efficacy of the Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system in differentiating benign from malignant and premalignant cysts (e.g. mucinous from non-mucinous cysts)
| Condition | Intervention |
|---|---|
|
Pancreatic Cysts |
Device: Needle-based Confocal Laser Endomicroscopy (nCLE) |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | In Vivo nCLE Study in the Pancreas With Endosonography of Cystic Tumors |
Resource links provided by NLM:
Further study details as provided by University of Chicago:
Primary Outcome Measures:
- Image interpretation criteria [ Time Frame: October 2011 ] [ Designated as safety issue: No ]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
Secondary Outcome Measures:
- Safety [ Time Frame: August 2011 ] [ Designated as safety issue: Yes ]Assess the safety of nCLE, by recording any possible adverse event or complications occurring during or shortly after the EUSFNA and nCLE procedure
- Technical feasibility [ Time Frame: August 2011 ] [ Designated as safety issue: No ]Assess the technical feasibility of nCLE: rate of interpretable images, technical ease of insertion and extraction of the nCLE probe in the needle, technical problems
- Image atlas of nCLE [ Time Frame: December 2011 ] [ Designated as safety issue: No ]Build an atlas of nCLE images in the pancreas
| Enrollment: | 65 |
| Study Start Date: | July 2010 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Device: Needle-based Confocal Laser Endomicroscopy (nCLE)
- Cellvizio
- pCLE
Patients will undergo the EUS-FNA procedure, as per standard of care, plus an additional nCLE procedure with the prototype probes, which will add 10 minutes maximum to the EUS-FNA procedure.
The nCLE probe will be positioned against the lining of the pancreatic cyst, and sequences will be acquired. After nCLE imaging, fine needle aspiration of the lesion will be performed, as usual.
Other Names:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01236300
Locations
| United States, California | |
| University of California Irvine | |
| Irvine, California, United States, CA 92868 | |
| Cedar Sinaï Medical Center | |
| Los Angeles, California, United States, CA90048 | |
| United States, Connecticut | |
| Yale University | |
| New Haven, Connecticut, United States, CT06520 | |
| United States, Florida | |
| Mayo Clinic Jacksonville | |
| Jacksonville, Florida, United States, FL32224 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, IL 60637 | |
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, WA98195 | |
| France | |
| Institut Paoli Calmettes | |
| Marseille, France, 13012 | |
| Germany | |
| Klinikum rechts der Isar | |
| Munich, Germany, 81675 | |
Sponsors and Collaborators
University of Chicago
Mauna Kea Technologies
Institut Paoli-Calmettes
Technische Universität München
Yale University
University of California, Irvine
Mayo Clinic
University of Washington
Cedars-Sinai Medical Center
Investigators
| Principal Investigator: | Irving Waxman, MD | University of Chicago |
More Information
No publications provided
| Responsible Party: | Vani Konda, Professor, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT01236300 History of Changes |
| Other Study ID Numbers: | MKT-2010-INSPECT, EUSFNA_02 |
| Study First Received: | November 5, 2010 |
| Last Updated: | January 14, 2013 |
| Health Authority: | United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University of Chicago:
|
Pancreatic cysts |
Additional relevant MeSH terms:
|
Pancreatic Cyst Cysts Neoplasms Pancreatic Diseases Digestive System Diseases |
Pancrelipase Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013