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

NCT01766284 | Completed

• 1 other identifier: PUSHOCTII
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  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.

Study Arms (1)

Niris 1300e OCT imaging

EXPERIMENTAL

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

Device: NIRIS 1300e

Interventions

NIRIS 1300e DEVICE

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.

Niris 1300e OCT imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Preventive Oncology International, Inc.: lead
• Imalux: collaborator

Study Sites (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

Location

Related Publications (3)

• 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.

  PMID: 20375808 BACKGROUND

• 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.

  PMID: 20134271 BACKGROUND

• 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.

  PMID: 23343696 BACKGROUND

Related Links

• Preventive Oncology International, Inc.

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site

Study Officials

• Jerome L Belinson, MD

  Preventive Oncology International

  PRINCIPAL INVESTIGATOR

• Rufiang Wu, MD

  Peking University Shenzhen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2012
• First Posted: January 11, 2013
• Study Start: November 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

CN (1)