Overview

This trial is active, not recruiting.

Condition cervical cancer
Treatments wide-field white light imaging, acetic acid, proflavine solution, wide-field fluorescence imaging
Sponsor M.D. Anderson Cancer Center
Start date June 2013
End date June 2018
Trial size 357 participants
Trial identifier NCT02335372, 2011-0396, NCI-2015-00339

Summary

Objectives:

Primary Objective: To perform a pilot clinical study to test multi-modal optical imaging for detection of cervical neoplasia in Brazil.

Secondary Objective: Analyze clinical data to establish the imaging modes which demonstrate the highest degree of correlation with disease state.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Initial wide-field white light images acquired of cervix in unpolarized and cross-polarized modes before application of 3-6% acetic acid. The clinician will identify all sites required for biopsy according to clinical impression, marking each location on the recorded unpolarized white light image. Topical application of 0.01% proflavine solution will then be applied for 1 minute, after which wide-field imaging in fluorescence mode will be performed. The clinician will then select up to 2 additional sites for biopsy based on the appearance of this wide-field fluorescence image, recording the location of each. The high-resolution microendoscope will then be used to acquire images at all sites selected for biopsy, followed by collection of biopsy specimens.
wide-field white light imaging
Initial wide-field white light images acquired of cervix in unpolarized and cross-polarized modes during cervical colposcopy.
acetic acid
3-6% acetic acid applied to cervix after wide-field while light imaging during colposcopy.
proflavine solution
Topical application of 0.01% proflavine solution applied for 1 minute to cervix after sites for biopsy have been identified during colposcopy.
wide-field fluorescence imaging
Wide-field imaging in fluorescence mode performed during cervical colposcopy after topical proflavine solution applied.

Primary Outcomes

Measure
Area Under the Receiver Operating Characteristic (ROC) Curve for Classifying Cervical Tissue into One of 2 Diagnostic Categories
time frame: 1 day

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: 1. Patients undergoing colposcopy 2. 18 years of age or older 3. Negative pregnancy test 4. Subjects must be willing and able to provide informed consent Exclusion Criteria: 1. Patients under 18 years of age 2. Positive pregnancy test 3. Subjects unwilling and unable to provide informed consent

Additional Information

Official title A Pilot Study of a Low-Cost Optical Imaging Tool for Cervical Cancer Screening in Brazil
Principal investigator Kathleen Schmeler, MD
Description Wide-field and high-resolution images of precancerous cervical lesions and normal uterine cervix will be obtained by imaging 357 patients, recruited from women presenting for colposcopic evaluation from the Prevention Department at Barretos Cancer Hospital, a MDACC Sister Institution, in Barretos, Brazil. Barretos Cancer Hospital will serve as the lead site for the study Initial wide-field white light images will be acquired in unpolarized and cross-polarized modes before application of 3-6% acetic acid. Routine colposcopy involves visual inspection of the cervix for aceto-whitening and will be followed by a second pair of white-light images in each polarization mode. The clinician will identify all sites required for biopsy according to clinical impression, marking each location on the recorded unpolarized white light image. Topical application of 0.01% proflavine solution will then be applied for 1 minute, after which wide-field imaging in fluorescence mode will be performed. The clinician will then select up to 2 additional sites for biopsy based on the appearance of this wide-field fluorescence image, recording the location of each. The high-resolution microendoscope will then be used to acquire images at all sites selected for biopsy, followed by collection of biopsy specimens. The entire imaging procedure should add less than 10 minutes to the standard colposcopy procedure.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.