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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cervical Intraepithelial Neoplasia
- Sponsor
- Preventive Oncology International, Inc.
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- To determine the accuracy of VIA plus Niris 1300e OCT enhanced gynecologic examination.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
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.(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.)