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CompletedNCT01766284PUSHOCTIIUpdated Feb 15, 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

An interventional study of NIRIS 1300e in Cervical Intraepithelial Neoplasia, Cervix Cancer and Cervical Dysplasia, sponsored by Preventive Oncology International, Inc.. Completed at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-15.

Sponsored by Preventive Oncology International, Inc. · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.
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Conditions studied

  • Cervical Intraepithelial Neoplasia
  • Cervix Cancer
  • Cervical Dysplasia
  • CIN
  • Human Papillomavirus

Keywords

  • Human Papillomavirus
  • Optical Coherence Tomography
  • Imaging Systems
  • Cervical intraepithelial neoplasia
  • Cervical Cancer
  • Cervical Dysplasia
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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 100 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Preventive Oncology International, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts 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

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Niris 1300e OCT imaging

    OCT imaging of the cervix using Niris 1300e will include computer aided calculations for epithelial brightness.

    Device: NIRIS 1300e

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.

06

What researchers measure

Primary outcomes

  1. 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

  1. 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.

07

Study locations

1 site
  • Peking University Shenzhen Hospital
    Shenzhen, Guangdong 518036, China
08

References and documents

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. PubMed 20375808 ↗
  • 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. PubMed 20134271 ↗
  • Belinson SE, Ledford K, Rasool N, Rollins A, Wilan N, Wang C, Rong X, Zhang W, Zhu Y, Tresser N, Wu R, Belinson JL. Cervical epithelial brightness by optical coherence tomography can determine histological grades of cervical neoplasia. J Low Genit Tract Dis. 2013 Apr;17(2):160-6. doi: 10.1097/LGT.0b013e31825d7bf0. PubMed 23343696 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01766284
Lead sponsor
Preventive Oncology International, Inc.
Collaborators
Imalux
Responsible party
Sponsor
First posted
Jan 11, 2013
Start date
Nov 2012
Primary completion
Nov 2012
Completion
Nov 2012
Last update
Feb 15, 2013

Study contacts

Jerome L Belinson, MD
principal investigator · Preventive Oncology International
Rufiang Wu, MD
principal investigator · Peking University Shenzhen Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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