Diagnostic Imaging Aid for Management of Cervical Lesions (FFC)

April 9, 2015 updated by: Michele Follen, Brookdale University Hospital Medical Center

Development and Application of a Diagnostic Imaging Aid for One-visit Management of Cervical Lesions in Low-resource Settings

A handheld digital colposcope which utilizes flurorescent light is being tested for the rapid detection and management of cervical lesions. The handheld research device captures cervical images which with the fluorescent light show the regions of cervical tissue that autofluoresce. The investigators will study the relationship between the level of fluorescence and the samples of tissue (biopsies) obtained from the patient as part of her routine care. The investigators will also compare the efficacy of the hand held device with the data being collected from the other research devices being tested by the team, i.e. the multispectral digital colposcopes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

618

Phase

  • Phase 2

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
      • Brooklyn, New York, United States, 11212
        • Brookdale University Hospital and 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women who are at least 18 years old
  • Women who are not pregnant as confirmed by a urine test
  • Women who are not breastfeeding
  • Women who understand the study procedures and can provide written informed consent

Exclusion Criteria:

  • Women who do not meet the inclusion criteria
  • Women who have had a hysterectomy

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: Standard of care plus imaging with research devices

Eligible patients who consent to participate in the research study will receive their standard of care colposcopy or treatment with the Loop Electrosurgical Excision Procedure (LEEP). Additionally, cervical images will be taken using the diagnostic imaging aid. The cervical images will be compared to the histopathology from the biopsies taken as part of the patients' standard of care for colposcopy. If the patient is presenting for the LEEP procedure, then she will be asked if one or two biopsies can be obtained prior to the procedure but after anesthesia has been administered.

The imaging device is not being used to make a diagnosis, but rather to develop an algorithm to make more efficacious and timely diagnoses of cervical neoplasias in the future.
Device: Diagnostic imaging aid for one-visit management of cervical lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of precancerous cervical lesions or cervical cancer
Time Frame: At point of care for colposcopy or treatment with LEEP (5 minutes).
Eligible patients who are referred to the colposcopy clinic for a diagnosis following an abnormal Pap smear will be asked to participate in the study. All participating women will receive their standard of care colposcopy as usual. In addition to their routine care, the handheld imaging research device will also be used to capture cervical images. The images will be analyzed and compared to the biopsies obtained. The imaging device will not be used to make a diagnosis. As part of the research study, one or two additional biopsies will be obtained if the patient agrees. These additional biopsies will serve as the control tissue, since they will be taken from tissue that appears normal through the colposcope.
At point of care for colposcopy or treatment with LEEP (5 minutes).

Collaborators and Investigators

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

Sponsor

Brookdale University Hospital Medical Center

Investigators

  • Principal Investigator: Michele Follen, PhD, Brookdale University Hospital and Medical Center

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

April 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

March 17, 2015

First Submitted That Met QC Criteria

March 30, 2015

First Posted (Estimate)

April 2, 2015

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-36

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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