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
2 other identifiers
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2018
CompletedFirst Posted
Study publicly available on registry
October 19, 2018
CompletedStudy Start
First participant enrolled
March 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 15, 2026
June 15, 2026
June 1, 2026
7.5 years
August 13, 2018
June 11, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Measure accuracy of using OCT to diagnose pancreatic cancer and compare with histology.
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.
Up to 3 years
Study Arms (1)
Diagnostic (resection, OCT)
EXPERIMENTALParticipants undergo resection. Resected tissues are analyzed via ultra-high resolution OCT.
Interventions
Undergo resection will be undertaken
Labs will be obtained to test for cancer cell derived exosomes
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary Dillhoff, MD
Ohio State University Comprehensive Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 13, 2018
First Posted
October 19, 2018
Study Start
March 26, 2019
Primary Completion (Estimated)
September 15, 2026
Study Completion (Estimated)
September 15, 2026
Last Updated
June 15, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share