Diagnostic Imaging Aid for Management of Cervical Lesions

Cervical Cancer Clinical Trial

— FFC  

Official title:

Development and Application of a Diagnostic Imaging Aid for One-visit Management of Cervical Lesions in Low-resource Settings

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02406365
• Other study ID #: 14-36
• Status: Not yet recruiting
• Phase: Phase 2
• First received: March 17, 2015
• Last updated: April 9, 2015
• Start date: April 2015
• Est. completion date: December 2017

Study information

• Verified date: April 2015
• Source: Brookdale University Hospital Medical Center
• Contact: Leonid Fradkin, PhD
• Phone: 718-240-8225
• Email: lfradkin[@]bhmcny.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 618
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• Cervical Intraepithelial Neoplasias
• Digital Colposcopy
• Precancerous Cervical Lesions
• Uterine Cervical Diseases
• Uterine Cervical Neoplasms

Intervention

Device:
• Diagnostic imaging aid for one-visit management of cervical lesions

Locations

Country	Name	City	State
United States	Brookdale University Hospital and Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Brookdale University Hospital Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No

External Links

•   Project website