Cervical Cancer Screening Study in Brazil

M.D. Anderson Cancer Center

Status: Completed

Conditions: Cervical Cancer

Treatments: Drug: Proflavine Solution; Procedure: Wide-Field Fluorescence Imaging; Drug: Acetic Acid; Procedure: Wide-Field White Light Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02335372

2011-0396

NCI-2015-00339 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Multi-Modal Optical Imaging of Cervix

Experimental group

Description:

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.

Treatment:

Procedure: Wide-Field Fluorescence Imaging

Drug: Proflavine Solution

Drug: Acetic Acid

Procedure: Wide-Field White Light Imaging