What this study is
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 details
- Official title
- Confocal Laser Endomicroscopy as an IMaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Conditions
- Pancreatic Cyst
- Enrolling
- 500 people
- Starts
- 2018-10-01
- Est. completion
- 2028-12-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (10)
9 openMayo Clinic Scottsdale Campus
Scottsdale, Arizona, United States
- Veronica Oria · ContactOria.Veronica@mayo.edu
- Rahul Pannala · Principal investigator
RecruitingStanford Hospital
Stanford, California, United States
- Samer El-Dika · ContactSamereld@stanford.edu
- Samer El-Dika · Principal investigator
RecruitingYale School of Medicine
New Haven, Connecticut, United States
- Chloe Bennett · Contactchloe.bennett@yale.edu
- Thiruvengadam Muniraj, MD, MRCP · Principal investigator
RecruitingThe Johns Hopkins Hospital
Baltimore, Maryland, United States
- Kylie Ning · Contactkning2@jhu.edu
- Anne Marie Lennon · Principal investigator
RecruitingBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
- Roya Dastjerdi, MPH · Contactrdastjer@bidmc.harvard.edu
- Mandeep Sawhney, MD · Principal investigator
RecruitingNYU Langone Health
Garden City, New York, United States
- Maria Marotta-Kollarus · ContactMaria.Kollarus@nyulangone.org
- Jessica Widmer, MD · Sub-investigator
- Tomas Gonda, MD · Principal investigator
RecruitingIcahn School of Medicine at Mount Sinai
New York, New York, United States
- Sharon Slomovich · ContactSharon.slomovich@snch.org
- Frank Gress, MD · Principal investigator
RecruitingThe Ohio State University Wexner Medical Center
Columbus, Ohio, United States
- Megan Fry · Contact614-293-1056Megan.Fry@osumc.edu
RecruitingBaylor College of Medicine
Houston, Texas, United States
- Chandra Kovvali · Contact713-798-2308ckovvali@bcm.edu
- Mohamed Othman, MD · Principal investigator
RecruitingParkview Hospital Randallia
Fort Wayne, Indiana, United States
Active, not recruiting
Study team
Sponsor
Ohio State University Comprehensive Cancer Center
Study ID 2017C0192
Principal investigator
Somashekar Krishna, MD, MPH
Ohio State University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.