Back to resultsDiagnostic Imaging Aid for Management of Cervical Lesions (FFC)
Primary Purpose
Cervical Cancer, Cervical Intraepithelial Neoplasias, Digital Colposcopy
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Diagnostic imaging aid for one-visit management of cervical lesions
Sponsored by
About this trial
This is an interventional diagnostic trial for Cervical Cancer
Eligibility Criteria
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
Sites / Locations
- Brookdale University Hospital and Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Standard of care plus imaging with research devices
Arm Description
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.
Outcomes
Primary Outcome Measures
Detection of precancerous cervical lesions or cervical cancer
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02406365
First Posted
March 17, 2015
Last Updated
April 9, 2015
Sponsor
Brookdale University Hospital Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02406365
Brief Title
Diagnostic Imaging Aid for Management of Cervical Lesions
Acronym
FFC
Official Title
Development and Application of a Diagnostic Imaging Aid for One-visit Management of Cervical Lesions in Low-resource Settings
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brookdale University Hospital Medical Center
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Cervical Intraepithelial Neoplasias, Digital Colposcopy, Precancerous Cervical Lesions
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
618 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of care plus imaging with research devices
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Diagnostic imaging aid for one-visit management of cervical lesions
Primary Outcome Measure Information:
Title
Detection of precancerous cervical lesions or cervical cancer
Description
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.
Time Frame
At point of care for colposcopy or treatment with LEEP (5 minutes).
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leonid Fradkin, PhD
Phone
718-240-8225
Email
lfradkin@bhmcny.org
First Name & Middle Initial & Last Name or Official Title & Degree
Thelma Carrillo, MPH
Phone
718-240-5978
Email
tcarrill@bhmcny.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Follen, PhD
Organizational Affiliation
Brookdale University Hospital and Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brookdale University Hospital and Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11212
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonid Fradkin, PhD
Phone
718-240-8225
Email
lfradkin@bhmcny.org
First Name & Middle Initial & Last Name & Degree
Thelma Carrillo, MPH
Phone
718-240-5978
Email
tcarrill@bhmcny.org
First Name & Middle Initial & Last Name & Degree
Michele Follen, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Diagnostic Imaging Aid for Management of Cervical Lesions
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