Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions (CLIMB)

February 7, 2024 updated by: Somashekar Krishna, Ohio State University

Confocal Laser Endomicroscopy as an IMaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions

The study schema is shown in Figure 4. (A) All patients referred to one of the participating academic centers for EUS evaluation of the PCL will be enrolled in the protocol if they satisfy inclusion criteria. Patient consent will be obtained during the clinic visit or prior to their EUS. EUS-guided nCLE imaging is first performed (B) followed by EUS-guided FNA and aspiration of cyst fluid. The cyst fluid is analyzed for CEA and cytology. As per institutional standard of care, the cyst fluid is also sent for molecular analysis. The results of the cyst fluid molecular analysis (B) will be utilized for the most likely diagnosis. Based on institutional multidisciplinary tumor board meetings, surgery is performed as indicated (C). Surgical histopathology serves as "gold standard" for diagnosis. It is anticipated that the majority of patients will undergo surgical resection after their EUS.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Clinic Scottsdale Campus
        • Contact:
        • Principal Investigator:
          • Rahul Pannala
    • California
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford hospital
        • Contact:
        • Principal Investigator:
          • Samer El-Dika
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale School of Medicine
        • Principal Investigator:
          • Thiruvengadam Muniraj, MD, MRCP
        • Contact:
    • Indiana
      • Fort Wayne, Indiana, United States, 46805
        • Active, not recruiting
        • Parkview Hospital Randallia
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • The Johns Hopkins Hospital
        • Principal Investigator:
          • Anne Marie Lennon
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
        • Principal Investigator:
          • Mandeep Sawhney, MD
    • New York
      • Garden City, New York, United States, 11530
        • Recruiting
        • NYU Langone Health
        • Contact:
        • Sub-Investigator:
          • Jessica Widmer, MD
        • Principal Investigator:
          • Tomas Gonda, MD
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Contact:
        • Principal Investigator:
          • Frank Gress, MD
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Wexner Medical Center
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:
        • Principal Investigator:
          • Mohamed Othman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects for this study will be identified from patients referred for diagnostic EUS-FNA of PCLs for a non-study indication by a physician responsible for their care (i.e., gastroenterologists, oncologists, general internists, and surgeons) either at the primary study center.

Description

Inclusion Criteria:

  • Patient age 18 years or older
  • All patients referred for EUS-FNA of accessible PCL where surgery is contemplated
  • Minimum cyst size should be ≥ 2.0 cm as determined by prior cross-sectional imaging studies

Exclusion Criteria:

  • Unable to obtain informed consent
  • Unable to tolerate the procedure
  • Women with known pregnancy at time of procedure
  • Patient age less than 18 years
  • Bleeding diathesis
  • Known allergy to fluorescein
  • Prior pancreatic cancer
  • Prior pancreatic surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of PCL diagnosis
Time Frame: 48 months
Diagnostic accuracy of confocal laser endomicroscopy and/or cyst fluid molecular markers and/or composite clinical and imaging features for the diagnosis of mucinous PCLs, PCLs with malignant potential, specific PCL types, and mucinous PCLs with advanced neoplasia.
48 months
Accuracy of risk-stratification of IPMNs
Time Frame: 48 months
Diagnostic accuracy of confocal laser endomicroscopy and/or composite clinical and imaging features for the risk stratification of IPMNs
48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Imaging quality
Time Frame: 48 months
Optimal quality of imaging obtained during in vivo confocal laser endomicroscopy of pancreatic cystic lesions
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Collaborators

American College of Gastroenterology
The National Pancreas Foundation

Investigators

  • Principal Investigator: Somashekar Krishna, MD, MPH, The Ohio State University Wexner Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 2, 2018

First Submitted That Met QC Criteria

April 2, 2018

First Posted (Actual)

April 10, 2018

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017C0192

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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