This pilot trial studies how well non-invasive imaging works compared to standard colposcopy in identifying patients with abnormal cervical tissue. Non-invasive imaging uses a special light source and filtering technology, and may be comparable to colposcopy in identifying patients with abnormal cervical tissue.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02767726.
PRIMARY OBJECTIVES:
I. To determine the feasibility of obtaining interpretable images prior to starting the colposcopy exam, biopsies, and endocervical curettage.
SECONDARY OBJECTIVES:
I. To determine the feasibility of performing MobileOCT’s imaging technology less than five minutes.
II. To determine the sensitivity and specificity of MobileOCT’s imaging technology to detect cervical dysplasia and/or cancer.
III. To compare test characteristics (i.e., sensitivity and specificity) between MobileOCT’s imaging technology and standard colposcopy.
OUTLINE:
Patients undergo imaging via MobileOCT multimodal mobile imaging device over 2-5 minutes. Patients undergo standard of care colposcopy with biopsy of the cervix.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorDanielle L. Burkland
