Coherence Imaging of the Cervical Epithelium With Scanning a/LCI

NCT03502798 | Completed Results FDA Device

• 2 other identifiers: Pro00070555_1R01CA167421
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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. 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. 2.features of individual cervical cells that indicate whether the cell is normal or abnormal (cervical dysplasia).

Conditions

Cervical Dysplasia

Outcome Measures

Primary Outcomes (2)

• Sensitivity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Positive Biopsies

  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

  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 Outcomes (1)

• Identification of T-zone by Scanning a/LCI Probe

  baseline

Study Arms (1)

scanning a/LCI

EXPERIMENTAL

Device: scanning a/LCI

Interventions

scanning a/LCI DEVICE

Imaging of the cervical epithelium using the scanning a/LCI device.

scanning a/LCI

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator
• Jacobi Medical Center: collaborator

Study Sites (2)

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Limitations and Caveats

The fragility of the instrument resulted in repeated breakage. Traveling from Durham to NYC to retrieve the broken instrument, repair it, and send it back several times set the timeline back substantially, resulting in insufficient time to perform the secondary outcome measure. Instrument fragility, complexity of instrument set up and initiation, and poor signal quality are responsible for the low yield of evaluable a/LCI scans.

Results Point of Contact

• Title: Dr. Adam Wax
• Organization: Duke University

a.wax@duke.edu

919-660-5143

Study Officials

• Adam Wax, Ph.D.

  professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 19, 2018
• Study Start: November 8, 2018
• Primary Completion: February 14, 2020
• Study Completion: February 14, 2020
• Last Updated: February 18, 2021
• Results First Posted: February 18, 2021

Record last verified: 2021-02

Locations

US (2)