๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-08-18

Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions (NCT03492151)

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

๐ŸŸข Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: Ohio State University Comprehensive Cancer Center

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Mayo Clinic Scottsdale Campus โ€” Scottsdale, Arizona

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (10 Sites)

  • Mayo Clinic Scottsdale Campus โ€” Scottsdale, Arizona
  • Stanford Hospital โ€” Stanford, California
  • Yale School of Medicine โ€” New Haven, Connecticut
  • Parkview Hospital Randallia โ€” Fort Wayne, Indiana
  • The Johns Hopkins Hospital โ€” Baltimore, Maryland
  • Beth Israel Deaconess Medical Center โ€” Boston, Massachusetts
  • NYU Langone Health โ€” Garden City, New York
  • Icahn School of Medicine at Mount Sinai โ€” New York, New York
  • The Ohio State University Wexner Medical Center โ€” Columbus, Ohio
  • Baylor College of Medicine โ€” Houston, Texas

๐Ÿ“ž Contact the Study Coordinator

Phone: (614) 293-1056

Email: Megan.Fry@osumc.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Pancreatic Cyst clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—