Brief Title
Diagnostic Imaging Aid for Management of Cervical Lesions
Official Title
Development and Application of a Diagnostic Imaging Aid for One-visit Management of Cervical Lesions in Low-resource Settings
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Detection of precancerous cervical lesions or cervical cancer
Condition
Cervical Cancer
Intervention
Diagnostic imaging aid for one-visit management of cervical lesions
Study Arms / Comparison Groups
Standard of care plus imaging with research devices
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
618
Start Date
April 2015
Completion Date
December 2017
Primary Completion Date
December 2016
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Michele Follen, PhD, 718-240-8225, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02406365
Organization ID
14-36
Responsible Party
Principal Investigator
Study Sponsor
Brookdale University Hospital Medical Center
Study Sponsor
Michele Follen, PhD, Principal Investigator, Brookdale University Hospital and Medical Center
Verification Date
April 2015