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

Cervical Intraepithelial Neoplasia Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01766284
• Other study ID #: PUSHOCTII
• Status: Completed
• Phase: N/A
• First received: November 4, 2012
• Last updated: February 12, 2013
• Start date: November 2012
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: Preventive Oncology International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Dysplasia
• Cervical Intraepithelial Neoplasia
• Cervix Cancer
• CIN
• Human Papillomavirus
• Neoplasms
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Peking University Shenzhen Hospital	Shenzhen	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Preventive Oncology International, Inc.	Imalux

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.

External Links

•   Preventive Oncology International, Inc.