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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnant

Trial design

Design model

Single group

Treatments tested in this trial

  • Optical Coherence Tomography

    Procedure/Surgery

    Undergo OCT

  • Therapeutic Conventional Surgery

    Procedure/Surgery

    Undergo resection will be undertaken

  • Laboratory Evaluation

    Diagnostic test

    Labs will be obtained to test for cancer cell derived exosomes

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: Diagnostic (resection, OCT)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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