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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)

Primary Purpose

Cervical Intraepithelial Neoplasia, Cervix Cancer, Cervical Dysplasia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NIRIS 1300e
Sponsored by
Preventive Oncology International, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Intraepithelial Neoplasia focused on measuring Human Papillomavirus, Optical Coherence Tomography, Imaging Systems, Cervical intraepithelial neoplasia, Cervical Cancer, Cervical Dysplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University Shenzhen Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Niris 1300e OCT imaging

Arm Description

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

Outcomes

Primary Outcome Measures

To determine the accuracy of VIA plus Niris 1300e OCT enhanced gynecologic examination.

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.

Full Information

First Posted
November 4, 2012
Last Updated
February 12, 2013
Sponsor
Preventive Oncology International, Inc.
Collaborators
Imalux
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1. Study Identification

Unique Protocol Identification Number
NCT01766284
Brief 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
Acronym
PUSHOCTII
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Preventive Oncology International, Inc.
Collaborators
Imalux

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Niris 1300e OCT imaging
Arm Type
Experimental
Arm Description
OCT imaging of the cervix using Niris 1300e will include computer aided calculations for epithelial brightness.
Intervention Type
Device
Intervention Name(s)
NIRIS 1300e
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerome L Belinson, MD
Organizational Affiliation
Preventive Oncology International
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rufiang Wu, MD
Organizational Affiliation
Peking University Shenzhen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518036
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
20375808
Citation
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.
Results Reference
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PubMed Identifier
20134271
Citation
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.
Results Reference
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PubMed Identifier
23343696
Citation
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.
Results Reference
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Links:
URL
http://www.poiinc.org
Description
Preventive Oncology International, Inc.

Learn more about this trial

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

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