A Non-Invasive Cervical Cancer Screening Modality: A Pilot Study

Abramson Cancer Center at Penn Medicine4 enrolled

Overview

Cervix cancer is a major global health concern. A way to screen and immediately treat precancerous lesions (Screen-and-Treat) is greatly needed. Developed by MobileOCT, polarized difference imaging and conventional imaging are used to identify suspicious lesions. We aim to compare this non-invasive method with colposcopy. Patients at the Dickens Clinic will have 3-5 minutes of non-invasive imaging before colposcopy. Pathology will be compared both to colposcopy impression versus MobileOCT.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Women With Abnormal Pap Smears

Interventions

non-invasive multimodal imagingDEVICE

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects capable of giving informed consent or have an acceptable surrogate capable of giving consent on subjects behalf. * Subjects are 18 years of age or older * Subjects are scheduled for colposcopy clinic based on screening with abnormal pap smear or have repeat colposcopy indicated for specific clinical indications, based off of American Society of Cosposcopy and Cytology. * Subjects are women. Exclusion Criteria: * Pregnancy. * Males (males do not have a cervix and thus cannot undergo colposcopy).

Locations (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Number of suspicious lesions identified

Time frame: 2 years

Data from ClinicalTrials.gov

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