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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01766284
First Posted: January 11, 2013
Last Update Posted: February 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Imalux
Information provided by (Responsible Party):
Preventive Oncology International, Inc.
  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: Intervention Model: Single Group Assignment
Masking: None (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. ]

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. ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: November 4, 2012
First Posted: January 11, 2013
Last Update Posted: February 15, 2013
Last Verified: February 2013

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