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
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ohio State University Comprehensive Cancer Center
- Phone Number: 800-293-5066
- Email: OSUCCCclinicaltrials@osumc.edu
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Recruiting
- Ohio State University Comprehensive Cancer Center
-
Contact:
- Mary E. Dillhoff, MD
- Phone Number: 614-293-7171
- Email: Mary.Dillhoff@osumc.edu
-
Principal Investigator:
- Mary E. Dillhoff, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diagnostic (resection, OCT)
Participants undergo resection.
Resected tissues are analyzed via ultra-high resolution OCT.
|
Undergo OCT
Other Names:
Undergo resection will be undertaken
Labs will be obtained to test for cancer cell derived exosomes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measure accuracy of using OCT to diagnose pancreatic cancer and compare with histology.
Time Frame: 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.
|
Up to 3 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mary Dillhoff, MD, Ohio State University Comprehensive Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Digestive System Neoplasms
- Digestive System Diseases
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Neoplasms, Glandular and Epithelial
- Neoplasms, Ductal, Lobular, and Medullary
- Pancreatic Intraductal Neoplasms
- Pancreatic Neoplasms
- Investigative Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Tomography
- Diagnostic Imaging
- Tomography, Optical
- Optical Imaging
- Tomography, Optical Coherence
Other Study ID Numbers
- OSU-18060
- NCI-2018-01534 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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