RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-10-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03492151

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient age 18 years or older
  2. * All patients referred for EUS-FNA of accessible PCL where surgery is contemplated
  3. * Minimum cyst size should be ≥ 2.0 cm as determined by prior cross-sectional imaging studies
  1. * Unable to obtain informed consent
  2. * Unable to tolerate the procedure
  3. * Women with known pregnancy at time of procedure
  4. * Patient age less than 18 years
  5. * Bleeding diathesis
  6. * Known allergy to fluorescein
  7. * Prior pancreatic cancer
  8. * Prior pancreatic surgery

Contacts and Locations

Study Contact

Megan Fry
CONTACT
614-293-1056
Megan.Fry@osumc.edu
Diana Burke
CONTACT
Diana.Burke@osumc.edu

Principal Investigator

Somashekar Krishna, MD, MPH
PRINCIPAL_INVESTIGATOR
The Ohio State University Wexner Medical Center

Study Locations (Sites)

Mayo Clinic Scottsdale Campus
Scottsdale, Arizona, 85259
United States
Stanford Hospital
Stanford, California, 94305
United States
Yale School of Medicine
New Haven, Connecticut, 06510
United States
Parkview Hospital Randallia
Fort Wayne, Indiana, 46805
United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
NYU Langone Health
Garden City, New York, 11530
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States
Baylor College of Medicine
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Ohio State University Comprehensive Cancer Center

  • Somashekar Krishna, MD, MPH, PRINCIPAL_INVESTIGATOR, The Ohio State University Wexner Medical Center

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 Registration Dates

Study Start Date2018-10-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2018-10-01
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Confocal laser endomicroscopy
  • pancreatic cancer
  • IPMN

Additional Relevant MeSH Terms

  • Pancreatic Cyst