Ultra-High Resolution Optical Coherence Tomography in Detecting Micrometer Sized Early Stage Pancreatic Cancer in Participants With Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT03711890|
Recruitment Status : Not yet recruiting
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Carcinoma Pancreatic Intraductal Papillary Mucinous Neoplasm, Pancreatobiliary-Type||Procedure: Optical Coherence Tomography Procedure: Therapeutic Conventional Surgery Diagnostic Test: Laboratory Evaluation||Not Applicable|
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 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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Diagnostic (resection, OCT)
Participants undergo resection. Resected tissues are analyzed via ultra-high resolution OCT.
Procedure: Optical Coherence Tomography
Other Name: OCT
Procedure: Therapeutic Conventional Surgery
Undergo resection will be undertaken
Diagnostic Test: Laboratory Evaluation
Labs will be obtained to test for cancer cell derived exosomes
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03711890
|Contact: Ohio State University Comprehensive Cancer Center||800-293-5066||OSUCCCClinicaltrials@osumc.edu|
|Contact: Nathan Donath||Nathan.Donath@osumc.edu|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center||Not yet recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Mary E. Dillhoff, MD 614-293-7171 Mary.Dillhoff@osumc.edu|
|Principal Investigator: Mary E. Dillhoff, MD|
|Principal Investigator:||Mary Dillhoff, MD||Ohio State University Comprehensive Cancer Center|