Cervical Dysplasia, Cervical Intraepithelial Neoplasia, Cervix Cancer, CIN, Human Papillomavirus
Conditions
Keywords
Human Papillomavirus, Optical Coherence Tomography, Imaging Systems, Cervical intraepithelial neoplasia, Cervical Cancer, Cervical Dysplasia
Brief summary
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
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.
Interventions
DEVICENIRIS 1300e
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.
Sponsors
Imalux
Preventive Oncology International, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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. |
Countries
China
Outcome results
None listed