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

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ClinicalTrials.gov Identifier: NCT03492151
Recruitment Status : Recruiting
First Posted : April 10, 2018
Last Update Posted : October 14, 2022
American College of Gastroenterology
The National Pancreas Foundation
Information provided by (Responsible Party):
Somashekar Krishna, Ohio State University

Brief Summary:
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.

Condition or disease
Pancreatic Cyst

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Confocal Laser Endomicroscopy as an IMaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Imaging quality [ Time Frame: 48 months ]
    Optimal quality of imaging obtained during in vivo confocal laser endomicroscopy of pancreatic cystic lesions

Biospecimen Retention:   Samples Without DNA
Pancreas cyst fluid from EUS-nCLE

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492151

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Contact: Megan Fry 614-293-1056 Megan.Fry@osumc.edu

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United States, Arizona
Mayo Clinic Scottsdale Campus Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Veronica Oria       Oria.Veronica@mayo.edu   
Principal Investigator: Rahul Pannala         
United States, California
Stanford Hospital Recruiting
Stanford, California, United States, 94305
Contact: Samer El-Dika       Samereld@stanford.edu   
Principal Investigator: Samer El-Dika         
United States, Connecticut
Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Contact: Christina Rose       christina.rose@yale.edu   
Principal Investigator: Thiruvengadam Muniraj, MD, MRCP         
United States, Indiana
Parkview Hospital Randallia Recruiting
Fort Wayne, Indiana, United States, 46805
Contact: Heather Sparks       Heather.Sparks@parkview.com   
Principal Investigator: Neil Sharma         
United States, Maryland
The Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Vaishnavi Sawant       vsawant1@jhmi.edu   
Principal Investigator: Anne Marie Lennon         
United States, Minnesota
University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Ghislaine Feussom       feuss001@umn.edu   
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Rebekah Dixon       rebekah.dixon@mountsinai.org   
Principal Investigator: Christopher DiMaio, MD         
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Megan Fry    614-293-1056    Megan.Fry@osumc.edu   
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Chandra Kovvali    713-798-2308    ckovvali@bcm.edu   
Principal Investigator: Mohamed Othman, MD         
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Manoop Bhutani, MD         
Principal Investigator: Manoop Bhutani, MD         
Sponsors and Collaborators
Ohio State University
American College of Gastroenterology
The National Pancreas Foundation
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Principal Investigator: Somashekar Krishna, MD, MPH The Ohio State University Wexner Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Somashekar Krishna, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT03492151    
Other Study ID Numbers: 2017C0192
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: October 14, 2022
Last Verified: September 2022

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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
Keywords provided by Somashekar Krishna, Ohio State University:
Confocal laser endomicroscopy
Additional relevant MeSH terms:
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Pancreatic Cyst
Pancreatic Diseases
Digestive System Diseases