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

Imaging and Detection of Micrometer Sized Early Stage Pancreatic Cancer by Using Endoscopic Ultra-High Resolution Optical Coherence Tomography (OCT) Using Resected Pancreatic Specimen, a Pilot Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03711890
Enrollment
75
Registered
2018-10-19
Start date
2019-03-26
Completion date
2026-09-15
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Carcinoma, Pancreatic Intraductal Papillary Mucinous Neoplasm, Pancreatobiliary-Type

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.

Interventions

PROCEDUREOptical Coherence Tomography

Undergo OCT

PROCEDURETherapeutic Conventional Surgery

Undergo resection will be undertaken

DIAGNOSTIC_TESTLaboratory Evaluation

Labs will be obtained to test for cancer cell derived exosomes

Sponsors

Ohio State University Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measure accuracy of using OCT to diagnose pancreatic cancer and compare with histology.Up to 3 yearsWill 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.

Countries

United States

Contacts

CONTACTOhio State University Comprehensive Cancer Center
OSUCCCClinicaltrials@osumc.edu800-293-5066
PRINCIPAL_INVESTIGATORMary Dillhoff, MD

Ohio State University Comprehensive Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026