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

Pancreatic Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03711890
• Other study ID #: OSU-18060
• Secondary ID: NCI-2018-01534
• Status: Recruiting
• Phase: N/A
• Start date: March 26, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: Ohio State University Comprehensive Cancer Center
• Contact: Ohio State University Comprehensive Cancer Center
• Phone: 800-293-5066
• Email: OSUCCCClinicaltrials[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Optical Coherence Tomography
Undergo OCT
• Therapeutic Conventional Surgery
Undergo resection will be undertaken

Diagnostic Test:
• Laboratory Evaluation
Labs will be obtained to test for cancer cell derived exosomes

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 3 years

External Links

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