Ultra-High Resolution Optical Coherence Tomography in Detecting Micrometer Sized Early Stage Pancreatic Cancer in Participants with Pancreatic Cancer

Not Applicable

Suspended

• Conditions: Pancreatic Carcinoma; Pancreatic Intraductal Papillary Mucinous Neoplasm, Pancreatobiliary-Type
• Interventions: Procedure: Optical Coherence Tomography; Procedure: Therapeutic Conventional Surgery; Diagnostic Test: Laboratory Evaluation

• Registration Number: NCT03711890
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

This trial studies how well ultra-high resolution optical coherence tomography works in detecting micrometer sized early stage pancreatic cancer in participants with pancreatic cancer. Ultra-high resolution optical coherence tomography may help to accurately identify pancreatic cancer in resected pancreatic specimens.

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the using of optical coherence tomography (OCT) to diagnose pancreatic cancer arising in the setting of intraductal papillary mucinous neoplasms (IPMN) using the resected pancreatic specimen.

II. To correlate OCT imaging diagnosis with histologic findings in the human pancreatic duct.

IPMN is a premalignant lesions arising in the pancreas. Typically, IPMNs are identified incidentally on imaging performed for other reason or related to vague abdominal pain or gastrointestinal complaints. In terms of IPMN, invasive cancer can be found in this setting between 20 to 50% of the time\[7\] Therefore, if a patient is diagnosed with IPMN, especially main duct type, the general recommendation is to undergo resection. We propose to assess the duct of the pancreatic specimen after resection to identify evidence of invasive malignancy by OCT imaging. Afterwards, the specimen will be undergoing histopathologic assessment using standard protocols. Our hypothesis is that OCT will accurately identify pancreatic cancer in resected pancreatic specimen. The assessment with OCT is non-invasive and will not harm to change the specimen prior to going to pathology for standard review. Future studies will then focus on using this imaging technique in vivo to endoscopically identify early stage pancreatic cancer.

Study Timeline

• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-10-16
• Study First Posted: 2018-10-19
• Study Start: 2019-03-26
• Status Verified: 2025-01
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Immediate surgery cohort: Adult patients with pancreatic cancer or IPMN
• Immediate surgery cohort: Informed consent will be obtained
• Adult patients undergoing pancreatic resection for a presumed IPMN

Exclusion Criteria

• Pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (resection, OCT)	Optical Coherence Tomography	Participants undergo resection. Resected tissues are analyzed via ultra-high resolution OCT.
Diagnostic (resection, OCT)	Laboratory Evaluation	Participants undergo resection. Resected tissues are analyzed via ultra-high resolution OCT.
Diagnostic (resection, OCT)	Therapeutic Conventional Surgery	Participants undergo resection. Resected tissues are analyzed via ultra-high resolution OCT.

Primary Outcome Measures

Name	Time	Method
Measure accuracy of using OCT to diagnose pancreatic cancer and compare with histology.	Up to 3 years	Will evaluate the accuracy of the optical coherence tomography (OCT) based diagnosis compare to the pathological diagnosis or the cancer cell derived exosomes test from the blood sample. Will compare the diagnosis results from the OCT imaging technology to standard histopathologic assessment and the blood test using 2-way tables. The agreement between two tests will be summarized with the overall agreement and the Cohen?s Kappa values.

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States