Study of the Diagnostic Efficacy of "Real Time" Niris 1300e Optical Coherence Tomography (OCT) Imaging System in the Management of Pre-invasive and Invasive Neoplasia of the Uterine Cervix

Preventive Oncology International, Inc.100 enrolled

Overview

Optical Coherence Tomography (OCT) is a technology using harmless near infra-red light scatter to produce an image. Prior studies with OCT have demonstrated that OCT of the uterine cervix can differentiate between grades of pre-invasive and invasive cervical disease and cancer. This study will evaluate the ability of the NIRIS 1300e imaging (OCT) system to detect pre-invasive cervical disease and cervical cancer.

B. Specific Aims 1. Primary. To determine the sensitivity, specificity, positive and negative predictive values for Niris 1300e OCT enhanced gynecologic examination (VIA-OCT vs.colposcopy-biopsy) for the detection of lesions equal or greater than cervical intraepithelial neoplasia II (CIN II) and cancer in a "real time" clinical evaluation. 2. Secondary. To examine the ease of use of Niris 1300e OCT in a real time clinical setting in order to assess its potential application during a "see and treat" or "single episode of care" clinic visit.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Cervical Intraepithelial Neoplasia Cervix Cancer Cervical Dysplasia

Interventions

NIRIS 1300eDEVICE

Optical coherence tomography (OCT) is similar to ultrasound pulse-echo imaging, with optical scatter rather than acoustic reflectivity being measured. OCT employs harmless near-infrared light technology which uses low coherence interferometry to produce an image (based on optical scattering) of tissue microstructure.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Female subjects \> 18 years of age 2. Subject must voluntarily sign a Patient Informed Consent Form specific to the study. 3. Subject must be physically and mentally willing to comply with all study requirements, especially conduct of a colposcopy exam. 4. Participant must be attending the Center for Cervical Diagnosis. Exclusion Criteria: 1. Based on clinical history, physical exam and patient presentation, the subject is unable to provide adequate informed consent and/or comply with the study requirements. 2. Subject is a prisoner. 3. Subject is pregnant. 4. Subject has had a hysterectomy 5. Subject has received prior pelvic radiotherapy.

Outcomes

Primary Outcomes

To determine the accuracy of VIA plus Niris 1300e OCT enhanced gynecologic examination.

Time frame: Study will be completed over a 4 day period with OCT and brightness determination as each patient is seen. During the next 4 months, we will conduct blinded reviews of the images to determine new sets of brightness numbers.

Secondary Outcomes

To compare OCT image (Niris 1300e) technology directly to colposcopy with biopsy for the detection of lesions equal or greater than cervical intraepithelial neoplasia II (CIN II) and cancer in a "real time" clinical evaluation.

Time frame: Study will be completed over a 4 day period with OCT and brightness determination as each patient is seen. During the next 4 months we will conduct blinded reviews of the images to determine new sets of brightness numbers.