Coherence Imaging of the Cervical Epithelium With Scanning a/LCI

February 1, 2021 updated by: Duke University

The purpose of this study is to develop a low coherence interferometry (LCI) endoscopic probe that can examine the cervix for evidence of cervical dysplasia. The device will make optical measurements of the cervix to determine:

  1. the difference between two different types of cervical cells: ectocervical cells and endocervical cells. Cervical dysplasia is most likely to occur at the junction between these two types of cells.
  2. features of individual cervical cells that indicate whether the cell is normal or abnormal (cervical dysplasia).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Jacobi Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older 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
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: scanning a/LCI
Device: scanning a/LCI
Imaging of the cervical epithelium using the scanning a/LCI device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Positive Biopsies
Time Frame: baseline

Sensitivity of the scanning a/LCI probe's ability to detect cervical dysplasia determined by calculating the percentage of correctly identified positive optical biopsies measured by the scanning a/LCI probe when compared to the gold standard, histopathology.

There are two dichotomies of classification used in this study: one that focuses on the morphological differences between cells (histology-based classification), and one that focuses on the urgency of corresponding treatment (response-based classification). In the histology-based classification, a result of benign alone is a negative result and a result of LSIL (low-grade squamous intraepithelial lesion) or HSIL (high-grade squamous epithelial lesion) is a positive result. In the response-based classification, both benign and LSIL are treated as negative results and HSIL is treated as a positive result.
baseline
Specificity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Negative Optical Biopsies
Time Frame: baseline

Specificity of the scanning a/LCI probe's ability to detect cervical dysplasia determined by calculating the percentage of correctly identified negative optical biopsies measured by the scanning a/LCI probe when compared to the gold standard, histopathology.

There are two dichotomies of classification used in this study: one that focuses on the morphological differences between cells (histology-based classification), and one that focuses on the urgency of corresponding treatment (response-based classification). In the histology-based classification, a result of benign alone is a negative result and a result of LSIL (low-grade squamous intraepithelial lesion) or HSIL (high-grade squamous intraepithelial lesion) is a positive result. In the response-based classification, both benign and LSIL are treated as negative results and HSIL is treated as a positive result.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of T-zone by Scanning a/LCI Probe
Time Frame: baseline
Ability of scanning a/LCI probe to correctly identify transformation zone (T-zone) compared to colpophotography
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Cancer Institute (NCI)
Jacobi Medical Center

Investigators

  • Principal Investigator: Adam Wax, Ph.D., professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2018

Primary Completion (Actual)

February 14, 2020

Study Completion (Actual)

February 14, 2020

Study Registration Dates

First Submitted

April 11, 2018

First Submitted That Met QC Criteria

April 11, 2018

First Posted (Actual)

April 19, 2018

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00070555_1
  • R01CA167421 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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