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Ultra-High Resolution Optical Coherence Tomography in Detecting Micrometer Sized Early Stage Pancreatic Cancer in Participants With Pancreatic Cancer

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03711890
Collaborator
National Cancer Institute (NCI) (NIH)
75
Enrollment
1
Location
1
Arm
34.8
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Optical Coherence Tomography
  • Procedure: Therapeutic Conventional Surgery
  • Diagnostic Test: Laboratory Evaluation
 N/A

Detailed Description

PRIMARY OBJECTIVES:

  1. 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.

  2. 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

Study Type:
Interventional
Anticipated 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 :
Feb 6, 2019
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

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 Names:
  • 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

    Primary Outcome Measures

    1. Measure accuracy of using OCT to diagnose pancreatic cancer and compare with histology. [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Ohio State University Comprehensive Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Mary Dillhoff, MD, Ohio State University Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    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
    • P30CA016058
    First Posted:
    Oct 19, 2018
    Last Update Posted:
    Dec 12, 2019
    Last Verified:
    Dec 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Pancreatic Neoplasms
    Pancreatic Intraductal Neoplasms

    Study Results

    No Results Posted as of Dec 12, 2019