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

Study Overview
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Brief Summary
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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.

Detailed Description
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B. Specific Aims 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. 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.

Official Title
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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 (PUSHOCTII)

Conditions
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CIN, Cervical Intraepithelial Neoplasia, Cervix Cancer, Cervical Dysplasia, Human Papillomavirus

Intervention / Treatment
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* Device: NIRIS 1300e


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female subjects > 18 years of age Subject must voluntarily sign a Patient Informed Consent Form specific to the study. Subject must be physically and mentally willing to comply with all study requirements, especially conduct of a colposcopy exam. Participant must be attending the Center for Cervical Diagnosis. Exclusion Criteria: 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. Subject is a prisoner. Subject is pregnant. Subject has had a hysterectomy Subject has received prior pelvic radiotherapy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Niris 1300e OCT imaging<br>OCT imaging of the cervix using Niris 1300e will include computer aided calculations for epithelial brightness. | Device: NIRIS 1300e<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the accuracy of VIA plus Niris 1300e OCT enhanced gynecologic examination. |  | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Papillomavirus, Optical Coherence Tomography, Imaging Systems, Cervical intraepithelial neoplasia, Cervical Cancer, Cervical Dysplasia