Diagnostic Imaging Aid for Management of Cervical Lesions (FFC)

Brookdale University Hospital Medical Center

Status and phase: Unknown; Phase 2

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02406365

14-36

Details and patient eligibility

About

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.

Enrollment: 618 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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618 participants in 1 patient group

Standard of care plus imaging with research devices

Experimental group

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.

Treatment:

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