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Diagnostic Imaging Aid for Management of Cervical Lesions (FFC)

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ClinicalTrials.gov Identifier: NCT02406365
Recruitment Status : Unknown
Verified April 2015 by Michele Follen, Brookdale University Hospital Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 2, 2015
Last Update Posted : April 10, 2015
Sponsor:
Information provided by (Responsible Party):
Michele Follen, Brookdale University Hospital Medical Center

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Cervical Intraepithelial Neoplasias Digital Colposcopy Precancerous Cervical Lesions Device: Diagnostic imaging aid for one-visit management of cervical lesions Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 618 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Development and Application of a Diagnostic Imaging Aid for One-visit Management of Cervical Lesions in Low-resource Settings
Study Start Date : April 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406365


Contacts
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Contact: Leonid Fradkin, PhD 718-240-8225 lfradkin@bhmcny.org
Contact: Thelma Carrillo, MPH 718-240-5978 tcarrill@bhmcny.org

Locations
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United States, New York
Brookdale University Hospital and Medical Center Not yet recruiting
Brooklyn, New York, United States, 11212
Contact: Leonid Fradkin, PhD    718-240-8225    lfradkin@bhmcny.org   
Contact: Thelma Carrillo, MPH    718-240-5978    tcarrill@bhmcny.org   
Principal Investigator: Michele Follen, MD, PhD         
Sponsors and Collaborators
Brookdale University Hospital Medical Center
Investigators
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Principal Investigator: Michele Follen, PhD Brookdale University Hospital and Medical Center

Additional Information:
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Responsible Party: Michele Follen, Chair of Department of Obstetrics and Gynecology, Brookdale University Hospital Medical Center
ClinicalTrials.gov Identifier: NCT02406365     History of Changes
Other Study ID Numbers: 14-36
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Cervical Intraepithelial Neoplasia
Uterine Cervical Diseases
Carcinoma in Situ
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type