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 - Full Text View

Purpose

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.

Condition	Intervention
Cervical Intraepithelial Neoplasia Cervix Cancer Cervical Dysplasia CIN Human Papillomavirus	Device: NIRIS 1300e

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer

U.S. FDA Resources

Further study details as provided by Preventive Oncology International, Inc.:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	November 2012
Study Completion Date:	November 2012
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Niris 1300e OCT imaging OCT imaging of the cervix using Niris 1300e will include computer aided calculations for epithelial brightness.	Device: NIRIS 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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766284

Locations

China, Guangdong
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036

Sponsors and Collaborators

Preventive Oncology International, Inc.

Imalux

Investigators

Principal Investigator:	Jerome L Belinson, MD	Preventive Oncology International
Principal Investigator:	Rufiang Wu, MD	Peking University Shenzhen Hospital

More Information

Additional Information:

Preventive Oncology International, Inc. This link exits the ClinicalTrials.gov site

Publications:

Wulan N, Rasool N, Belinson SE, Wang C, Rong X, Zhang W, Zhu Y, Yang B, Tresser NJ, Mohr M, Wu R, Belinson JL. Study of the diagnostic efficacy of real-time optical coherence tomography as an adjunct to unaided visual inspection with acetic acid for the diagnosis of preinvasive and invasive neoplasia of the uterine cervix. Int J Gynecol Cancer. 2010 Apr;20(3):422-7. doi: 10.1111/IGC.0b013e3181d09fbb.

Liu Z, Belinson SE, Li J, Yang B, Wulan N, Tresser NJ, Wang C, Mohr M, Zhang L, Zhou Y, Weng L, Wu R, Belinson JL. Diagnostic efficacy of real-time optical coherence tomography in the management of preinvasive and invasive neoplasia of the uterine cervix. Int J Gynecol Cancer. 2010 Feb;20(2):283-7. doi: 10.1111/IGC.0b013e3181cd1810.

Responsible Party:	Preventive Oncology International, Inc.
ClinicalTrials.gov Identifier:	NCT01766284 History of Changes
Other Study ID Numbers:	PUSHOCTII
Study First Received:	November 4, 2012
Last Updated:	February 12, 2013
Health Authority:	China: Ethics Committee United States: Institutional Review Board

Keywords provided by Preventive Oncology International, Inc.:

Human Papillomavirus
Optical Coherence Tomography
Imaging Systems

Cervical intraepithelial neoplasia
Cervical Cancer
Cervical Dysplasia

Additional relevant MeSH terms:

Uterine Cervical Neoplasms
Uterine Cervical Dysplasia
Uterine Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Precancerous Conditions
Neoplasms

Cervical Intraepithelial Neoplasia
Carcinoma in Situ
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 21, 2013

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)