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

The Ohio State University

Status: Suspended

Conditions: Pancreatic Intraductal Papillary Mucinous Neoplasm, Pancreatobiliary-Type; Pancreatic Carcinoma

Treatments: Diagnostic Test: Laboratory Evaluation; Procedure: Therapeutic Conventional Surgery; Procedure: Optical Coherence Tomography

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03711890

NCI-2018-01534 (Registry Identifier)

OSU-18060

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Diagnostic (resection, OCT)

Experimental group

Description:

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

Treatment:

Procedure: Optical Coherence Tomography

Procedure: Therapeutic Conventional Surgery

Diagnostic Test: Laboratory Evaluation