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

NCT ID: NCT03711890

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-26

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Pancreatic Carcinoma Pancreatic Intraductal Papillary Mucinous Neoplasm, Pancreatobiliary-Type

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (resection, OCT)

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

Group Type EXPERIMENTAL

Optical Coherence Tomography

Intervention Type PROCEDURE

Undergo OCT

Therapeutic Conventional Surgery

Intervention Type PROCEDURE

Undergo resection will be undertaken

Laboratory Evaluation

Intervention Type DIAGNOSTIC_TEST

Labs will be obtained to test for cancer cell derived exosomes

Interventions

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Optical Coherence Tomography

Undergo OCT

Intervention Type PROCEDURE

Therapeutic Conventional Surgery

Undergo resection will be undertaken

Intervention Type PROCEDURE

Laboratory Evaluation

Labs will be obtained to test for cancer cell derived exosomes

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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OCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Mary Dillhoff

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary Dillhoff, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

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Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Related Links

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http://cancer.osu.edu

The Jamelinesline

Other Identifiers

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NCI-2018-01534

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-18060

Identifier Type: -

Identifier Source: org_study_id

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