Actively Recruiting
Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
Led by Ohio State University Comprehensive Cancer Center · Updated on 2025-08-22
500
Participants Needed
10
Research Sites
430 weeks
Total Duration
On this page
Sponsors
O
Ohio State University Comprehensive Cancer Center
Lead Sponsor
A
American College of Gastroenterology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient age 18 years or older
- All patients referred for EUS-FNA of accessible pancreatic cystic lesions where surgery is considered
- Minimum cyst size of 2.0 cm or larger based on prior imaging studies
You will not qualify if you...
- Unable to provide informed consent
- Unable to tolerate the procedure
- Women who are pregnant at the time of the procedure
- Patient age less than 18 years
- Bleeding disorders
- Known allergy to fluorescein
- History of pancreatic cancer
- History of prior pancreatic surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Mayo Clinic Scottsdale Campus
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Stanford Hospital
Stanford, California, United States, 94305
Actively Recruiting
3
Yale School of Medicine
New Haven, Connecticut, United States, 06510
Actively Recruiting
4
Parkview Hospital Randallia
Fort Wayne, Indiana, United States, 46805
Active, Not Recruiting
5
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
6
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
7
NYU Langone Health
Garden City, New York, United States, 11530
Actively Recruiting
8
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
9
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
10
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Megan Fry
CONTACT
D
Diana Burke
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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