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

NCT01236300 | Completed Results DMC

• 2 other identifiers: MKT-2010-INSPECTEUSFNA_02
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Pancreatic Cysts

Keywords

Pancreatic cysts

Outcome Measures

Primary Outcomes (4)

• Sensitivity

  Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2. For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review. In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients' clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available.

  October 2011

• Specificity

  Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2. For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review. In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients' clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available.

  October 2011

• PPV (Positive Predictive Value)

  Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2. For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review. In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients' clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available.

  October 2011

• NPV (Negative Predictive Value)

  Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2. For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review. In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients' clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available.

  October 2011

Secondary Outcomes (1)

• Overall Complication Rate

  August 2011

Study Arms (1)

Cellvizio system

EXPERIMENTAL

Device: Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system

Interventions

Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system DEVICE

Cellvizio system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Allergy to fluorescein
• Pregnancy or breast-feeding

Sponsors & Collaborators

• University of Chicago: lead
• Mauna Kea Technologies: collaborator
• Institut Paoli-Calmettes: collaborator
• Technical University of Munich: collaborator
• Yale University: collaborator
• University of California, Irvine: collaborator
• Mayo Clinic: collaborator
• University of Washington: collaborator
• Cedars-Sinai Medical Center: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, IL 60637, United States

Location

MeSH Terms

Conditions

Pancreatic Cyst

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Vani J.A. Konda
• Organization: University of Chicago Medical Center

vkonda@medicine.bsd.uchicago.edu

773-702-1460

Study Officials

• Irving Waxman, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: November 8, 2010
• Study Start: July 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: May 1, 2012
• Last Updated: June 8, 2016
• Results First Posted: March 31, 2015

Record last verified: 2016-05

Locations

US (1)