This clinical trial determines feasibility of optical coherence tomography (OCT) probe for screening and diagnosis of colorectal cancer during routine colonoscopy. Diagnostic imaging tools, such as OCT probe, may help find and diagnose disease and find out how far the disease has spread.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05179837.
PRIMARY OBJECTIVE:
I. To demonstrate the procedural feasibility of OCT during routine colonoscopy.
SECONDARY OBJECTIVES:
I. To describe safety of OCT probe during routine colonoscopy.
II. To evaluate the quality of OCT images using a machine learning algorithm.
III. To explore the diagnosis agreement between OCT imaging and pathology when a lesion is biopsied.
OUTLINE:
Patients undergo imaging with OCT probe over 10 minutes during routine colonoscopy.
After completion of study treatment, patients are followed up at 48 hours after colonoscopy procedure.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorVladimir Kushnir
