Coherence Imaging of the Cervical Epithelium With Scanning a/LCI

Not Applicable

Completed

• Conditions: Cervical Dysplasia
• Interventions: Device: scanning a/LCI

• Registration Number: NCT03502798
• Lead Sponsor: Duke University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-04-11
• Study First Posted: 2018-04-19
• Study Start: 2018-11-08
• Primary Completion: 2020-02-14
• Study Completion: 2020-02-14
• Status Verified: 2021-02
• Results First Submitted: 2021-02-01
• Results First Submitted QC: 2021-02-01
• Last Update Submitted: 2021-02-01
• Results First Posted: 2021-02-18
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
scanning a/LCI	scanning a/LCI	-

Primary Outcome Measures

Name	Time	Method
Sensitivity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Positive Biopsies	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.
Specificity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Negative Optical Biopsies	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.

Secondary Outcome Measures

Name	Time	Method
Identification of T-zone by Scanning a/LCI Probe	baseline	Ability of scanning a/LCI probe to correctly identify transformation zone (T-zone) compared to colpophotography

Trial Locations

Locations (2)

Jacobi Medical Center; 🇺🇸 Bronx, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States