Clinical trial · Interventional
Cervical Cancer Screening Study in Brazil
A Pilot Study of a Low-Cost Optical Imaging Tool for Cervical Cancer Screening in Brazil
NCT02335372CI-TRIAL-00054388completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acetic Acid | Drug | — | UNRESOLVED |
| Proflavine Solution | Drug | — | UNRESOLVED |
| Wide-Field Fluorescence Imaging | Procedure | — | UNRESOLVED |
| Wide-Field White Light Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Multi-Modal Optical Imaging of Cervix
- 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.
- interventionNames
- Procedure: Wide-Field White Light Imaging
- Drug: Acetic Acid
- Drug: Proflavine Solution
- Procedure: Wide-Field Fluorescence Imaging
Primary outcomes (1)
- measure
- Area Under the Receiver Operating Characteristic (ROC) Curve for Classifying Cervical Tissue into One of 2 Diagnostic Categories
- timeFrame
- 1 day
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.