Coherence Imaging of the Cervical Epithelium

The purpose of this study is to develop a multiplexed low coherence interferometry (mLCI) endoscopic probe for mapping the epithelial types of the cervix. This vaginal mLCI probe will obtain optical measurements from the cervix. These measurements can be used to create a map of the surface cells that distinguishes ectocervical epithelia, endocervical epithelia, and the squamocolumnar junction (t-zone), which is the region where cervical dysplasia is most likely to occur.

Study Overview

• Status: Completed
• Conditions: Cervical Epithelia
• Intervention / Treatment: Device: mLCI Device

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Jacobi Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 36 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• able to provide informed consent
• willing to abstain from sexual intercourse for at least 24 hours before study visit

Exclusion Criteria:

• pregnant
• using an intrauterine device (IUD)
• have a current gynecological infection or discharge
• have had any cervical surgery
• had medical or cosmetic surgery involving the reproductive organs or genitals within the past 6 months
• currently enrolled in any research studies involving the application of vaginal formulations
• employed or supervised by the study investigators
• have any other condition, that, in the opinion of the study clinician, would contraindicate participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mLCI imaging; mLCI device images cervical epithelium	Device: mLCI Device; imaging of cervical epithelium using mLCI device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Interferometric Data Acquired From Cervical Epithelium	measured by: ability to receive interferometric data from at least one portion of the cervical epithelium	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Automated Classification of Cervical Epithelium	The number of patients for which an interferometric tissue classification was made using optical mLCI data	day 1
Number and Frequency of Adverse Events	Number of adverse events experienced by patients during the mLCI study.	day 1

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Cancer Institute (NCI); Jacobi Medical Center
• Investigators: Principal Investigator: Adam Wax, Ph.D., PROFESSOR

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2016
• Primary Completion (Actual): October 24, 2017
• Study Completion (Actual): October 24, 2017

Study Registration Dates

• First Submitted: September 1, 2016
• First Submitted That Met QC Criteria: September 12, 2016
• First Posted (Estimate): September 16, 2016

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: October 17, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Pro00070555; R01CA167421 (U.S. NIH Grant/Contract)