NCT03492151 Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
| NCT ID | NCT03492151 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University Comprehensive Cancer Center |
| Condition | Pancreatic Cyst |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2018-10-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2018-10-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Somashekar Krishna, MD, MPH
PRINCIPAL INVESTIGATOR
Ohio State University
Frequently Asked Questions
Who can join the NCT03492151 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Cyst. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03492151 currently recruiting?
Yes, NCT03492151 is actively recruiting participants. Contact the research team at Megan.Fry@osumc.edu for enrollment information.
Where is the NCT03492151 trial being conducted?
This trial is being conducted at Scottsdale, United States, Stanford, United States, New Haven, United States, Fort Wayne, United States and 6 additional locations.
Who is sponsoring the NCT03492151 clinical trial?
NCT03492151 is sponsored by Ohio State University Comprehensive Cancer Center. The principal investigator is Somashekar Krishna, MD, MPH at Ohio State University. The trial plans to enroll 500 participants.