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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 : Unknown
Verified December 2019 by Mary Dillhoff, Ohio State University Comprehensive Cancer Center.
Recruitment status was:  Recruiting
First Posted : October 19, 2018
Last Update Posted : December 12, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mary Dillhoff, Ohio State University Comprehensive Cancer Center

Study Description
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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.

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : February 6, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Diagnostic (resection, OCT)
Participants undergo resection. Resected tissues are analyzed via ultra-high resolution OCT.
 Procedure: Optical Coherence Tomography
Undergo OCT
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Ohio State University Comprehensive Cancer Center 800-293-5066 OSUCCCClinicaltrials@osumc.edu

Locations
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United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Mary E. Dillhoff, MD    614-293-7171    Mary.Dillhoff@osumc.edu   
Principal Investigator: Mary E. Dillhoff, MD         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Mary Dillhoff, MD Ohio State University Comprehensive Cancer Center
More Information
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Additional Information:

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Responsible Party: Mary Dillhoff, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03711890    
Other Study ID Numbers: OSU-18060
NCI-2018-01534 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA016058 ( U.S. NIH Grant/Contract )
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Pancreatic Intraductal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
 Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type