The Use of the LuViva Advanced Cervical Scan to Identify Women at High-Risk for Cervical Neoplasia

March 19, 2025 updated by: Guided Therapeutics
This study is designed to demonstrate that a multimodal hyperspectral device (LuViva) is able to segregate women with abnormal screening tests into Low and High risk groups for the purpose of determining whether they require enhanced colposcopy and additional biopsies in order to increase detection of CIN2+ cervical disease.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This study is a matched pair design, single-arm study with the following two treatments: current standard of care (SOC) and the LuViva study device. After undergoing the LuViva test, all study subjects will first undergo the SOC (i.e., nominal) colposcopy, with the colposcopist noting on the case report form (CRF), locations of lesions with colposcopy impression of CIN1+. Then the colposcopist will employ enhanced colposcopy measures that include the use on Lugol's solution and green/blue filters. The colposcopist will note on the CRF any additional lesions that became evident as a result of these enhanced measures, regardless of colposcopic impression. Biopsies of these lesions will be taken. Biopsies identified using SOC practices will be placed in vials labeled "SOC Samples". Biopsies identified using enhanced practices will be placed in vials labeled "Additional Samples". The colposcopist will then take a biopsy from any quadrant at the squamocolumnar junction (SCJ) in which a lesion was not observed. These biopsies will be placed in the vial labeled "Additional Samples". Once all colposcopy procedures are completed, biopsies of lesions collected, and biopsies of any non-lesion identified quadrants collected, an ECC, if indicated, will be collected. If an ECC would have been taken per SOC practices, it will be placed in a vial labeled "SOC ECC". ECCs collected per enhanced procedures will be placed in a vial labeled "Additional ECC". The study is a matched pair design because all subjects are tested with the LuViva device, and all will undergo both the nominal (minimal) colposcopy and biopsy treatment pursuant to ASCCP Guidelines as well as enhanced colposcopy and biopsy. By analyzing all biopsy specimens from SOC procedures and enhanced procedures, it can be determined 1) Whether enhanced procedures can be justified when the LuViva test indicates High-risk by the increase in detection of CIN2+ and 2) That when LuViva indicates Low-risk, that enhanced procedures (in the absence of a LuViva High-risk result) are not the reason for increased detection of CIN2+. Subjects will be enrolled during their normally scheduled colposcopy visit and will be recruited from the pool of patients that are referred to colposcopy based on the ASCCP Guidelines published in April 2020. The total number of enrolled female subjects pooled across all clinical sites combined will not exceed 500 in order to target an evaluable cohort of approximately 400 women.

Study Type

Interventional

Enrollment (Estimated)

400

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
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama Birmingham- Heersink School of Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University- Winship Cancer Institute
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Great Lakes Bay Health Centers
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Tidewater Clinical Research

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Able to read or understand and give informed consent
  • Referral Pap test within 120 days

  • Scheduled for colposcopy based on the 2019 ASCCP Management Guidelines that fall within the 4% to 59% Immediate CIN3+ risk with the exception of women who lack a cervix or may be pregnant and are recommended to colposcopy.*

    • Notes: The rationale for defining the referral inclusion criteria as women scheduled for colposcopy is that this group has been identified with having a significant likelihood of being diagnosed with CIN2+ over the two year period after being referred to colposcopy because of an abnormal screening test or tests. For example, the ALTS results showed that women with ASC-US plus high-risk HPV, LSIL, ASC-H, AGC and HSIL all had a likelihood of CIN2+ of approximately 10% to 20% or greater in the cases of ASC-H and HSIL (5). More recently, it has been shown that this threshold also carries with it a 4% or greater likelihood of immediate CIN3+ (12).

Exclusion Criteria:

  • Pregnancy
  • Menstruating on the day of colposcopy and LuViva test
  • Radiation therapy to her genitourinary system within 1 year
  • Prior hysterectomy in which cervix was removed
  • Congenital anatomical cervical variant (e.g., double cervix)
  • Friable cervix at the time of the study (i.e., a cervix that bleeds easily upon minimal contact or trauma)
  • Post-coital or other significant bleeding at the time of the exam
  • Excessive cervical mucous or discharge that cannot be removed and is significant enough, in the opinion of the Investigator, to interfere with a Pap test or colposcopy, resulting from inflammation, bacterial infection or other sources
  • History of any photosensitizing disease or other disease affected by Ultra-violet radiation, (e.g., pophyria, Lupus Erythematosus).
  • Undergoing phototherapy
  • Recent use of photosensitizing agents, such as fluoroquinolones or retinoids
  • Under-screened populations - defined as those women who have not been screened within the past 5 years who also screen positive for any HPV genotype

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: Singe-arm Study
Experimental device being evaluated for sensitivity and specificity.
Diagnostic test: LuViva Advanced Cervical Scan
Multimodal hyperspectral device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of Diagnostic Device
Time Frame: up to 60 days after completion of enrollment
LuViva's ability to correctly identify diseased tissue. LuViva result indicated High-risk and the pathology results indicate the presence of disease cervical tissue.
up to 60 days after completion of enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity of Diagnostic Device
Time Frame: up to 60 days after completion of enrollment
LuViva's ability to correctly identify non diseased tissue. LuViva result indicated Low-risk and the pathology results did not indicate the presence of disease cervical tissue.
up to 60 days after completion of enrollment

Collaborators and Investigators

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

Sponsor

Guided Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 5, 2023

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

May 28, 2021

First Submitted That Met QC Criteria

June 2, 2021

First Posted (Actual)

June 7, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-03-01-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Yes

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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