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

Primary Purpose

Pancreatic Carcinoma, Pancreatic Intraductal Papillary Mucinous Neoplasm, Pancreatobiliary-Type

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optical Coherence Tomography
Therapeutic Conventional Surgery
Laboratory Evaluation
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio State University Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (resection, OCT)

Arm Description

Participants undergo resection. Resected tissues are analyzed via ultra-high resolution OCT.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 13, 2018
Last Updated
November 22, 2022
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03711890
Brief Title
Ultra-High Resolution Optical Coherence Tomography in Detecting Micrometer Sized Early Stage Pancreatic Cancer in Participants With Pancreatic Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 26, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Carcinoma, Pancreatic Intraductal Papillary Mucinous Neoplasm, Pancreatobiliary-Type

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (resection, OCT)
Arm Type
Experimental
Arm Description
Participants undergo resection. Resected tissues are analyzed via ultra-high resolution OCT.
Intervention Type
Procedure
Intervention Name(s)
Optical Coherence Tomography
Other Intervention Name(s)
OCT
Intervention Description
Undergo OCT
Intervention Type
Procedure
Intervention Name(s)
Therapeutic Conventional Surgery
Intervention Description
Undergo resection will be undertaken
Intervention Type
Diagnostic Test
Intervention Name(s)
Laboratory Evaluation
Intervention Description
Labs will be obtained to test for cancer cell derived exosomes
Primary Outcome Measure Information:
Title
Measure accuracy of using OCT to diagnose pancreatic cancer and compare with histology.
Description
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.
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ohio State University Comprehensive Cancer Center
Phone
800-293-5066
Email
OSUCCCClinicaltrials@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Dillhoff, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary E. Dillhoff, MD
Phone
614-293-7171
Email
Mary.Dillhoff@osumc.edu
First Name & Middle Initial & Last Name & Degree
Mary E. Dillhoff, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamelinesline

Learn more about this trial

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

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