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)

This study has been completed.
Sponsor:
Collaborator:
Imalux
Information provided by (Responsible Party):
Preventive Oncology International, Inc.
ClinicalTrials.gov Identifier:
NCT01766284
First received: November 4, 2012
Last updated: February 12, 2013
Last verified: February 2013
  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:


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

  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.
  Eligibility

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

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.
  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:
Publications:
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:
Neoplasms
Uterine Cervical Neoplasms
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Carcinoma in Situ
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Precancerous Conditions
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on April 20, 2014