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2019-03-26
2025-12-31
2025-12-31
75
NCT03711890
Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
INTERVENTIONAL
Ultra-High Resolution Optical Coherence Tomography in Detecting Micrometer Sized Early Stage Pancreatic Cancer in Participants With Pancreatic Cancer
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-08-13 | N/A | 2025-03-25 |
2018-10-16 | N/A | 2025-03-30 |
2018-10-19 | N/A | 2025-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Diagnostic (resection, OCT) Participants undergo resection. Resected tissues are analyzed via ultra-high resolution OCT. | PROCEDURE: Optical Coherence Tomography
PROCEDURE: Therapeutic Conventional Surgery
DIAGNOSTIC_TEST: Laboratory Evaluation
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
