Diagnostic Imaging Aid for Management of Cervical Lesions

NCT02406365 | Unknown Phase 2

• 1 other identifier: 14-36
• Study Type: interventional
• Target: 618
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; Cervical Intraepithelial Neoplasias; Digital Colposcopy; Precancerous Cervical Lesions

Outcome Measures

Primary Outcomes (1)

• 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.

  At point of care for colposcopy or treatment with LEEP (5 minutes).

Study Arms (1)

Standard of care plus imaging with research devices

EXPERIMENTAL

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

Interventions

Diagnostic imaging aid for one-visit management of cervical lesions DEVICE

Standard of care plus imaging with research devices

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women who have had a hysterectomy

Sponsors & Collaborators

• Brookdale University Hospital Medical Center: lead

Study Sites (1)

Brookdale University Hospital and Medical Center

Brooklyn, New York, 11212, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Michele Follen, PhD

  Brookdale University Hospital and Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonid Fradkin, PhD

CONTACT

718-240-8225; lfradkin@bhmcny.org

Thelma Carrillo, MPH

CONTACT

718-240-5978; tcarrill@bhmcny.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: April 2, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: April 10, 2015

Record last verified: 2015-04

Locations

US (1)