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Standard of care plus imaging with research devices for Cervical Dysplasia (FFC Trial)

Phase 2
Waitlist Available
Led By Michele Follen, PhD
Research Sponsored by Brookdale University Hospital Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at point of care for colposcopy or treatment with leep (5 minutes).
Awards & highlights

FFC Trial 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.

Eligible Conditions
  • Cervical Dysplasia
  • Cervical Cancer
  • Digital Colposcopy

FFC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at point of care for colposcopy or treatment with leep (5 minutes).
This trial's timeline: 3 weeks for screening, Varies for treatment, and at point of care for colposcopy or treatment with leep (5 minutes). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Detection of precancerous cervical lesions or cervical cancer

FFC Trial Design

1Treatment groups
Experimental Treatment
Group I: Standard of care plus imaging with research devicesExperimental Treatment1 Intervention
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.

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Who is running the clinical trial?

Brookdale University Hospital Medical CenterLead Sponsor
7 Previous Clinical Trials
2,545 Total Patients Enrolled
Michele Follen, PhDPrincipal InvestigatorBrookdale University Hospital and Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Diagnostic Imaging Aid for Management of Cervical Lesions
Michele Follen 2015. "Diagnostic Imaging Aid for Management of Cervical Lesions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02406365.
~61 spots leftby May 2025
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