NCT02335372

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2015

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2021

Completed
Last Updated

October 12, 2021

Status Verified

October 1, 2021

Enrollment Period

8.4 years

First QC Date

January 7, 2015

Last Update Submit

October 8, 2021

Conditions

Cervical Cancer

Keywords

Cervical cancerCervical neoplasiaCervical cancer screeningColposcopyWide-field white light imagingWide-field fluorescence imagingAcetic acidProflavine solution

Outcome Measures

Primary Outcomes (1)

  • Area Under the Receiver Operating Characteristic (ROC) Curve for Classifying Cervical Tissue into One of 2 Diagnostic Categories

    Data used to develop an algorithm to maximize the area under the receiver operating characteristic (ROC) curve for classifying tissue into one of 2 diagnostic categories (high grade squamous intraepithelial lesions; normal or low grade squamous intraepithelial lesions). Descriptive statistics used to summarize the demographic and clinical characteristics of patients by diagnostic category. Descriptive statistics and boxplots used to summarize nuclear size and N/C by diagnostic category. Logistic regression methods used with the training set to model the logit of the probability of being classified as a high grade squamous intraepithelial lesion and to identify the parameters and threshold values which maximize the area under the ROC curve.

    1 day

Study Arms (1)

Multi-Modal Optical Imaging of Cervix

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.

Procedure: Wide-Field White Light ImagingDrug: Acetic AcidDrug: Proflavine SolutionProcedure: Wide-Field Fluorescence Imaging

Interventions

Wide-Field White Light ImagingPROCEDURE

Initial wide-field white light images acquired of cervix in unpolarized and cross-polarized modes during cervical colposcopy.

Multi-Modal Optical Imaging of Cervix
Acetic AcidDRUG

3-6% acetic acid applied to cervix after wide-field while light imaging during colposcopy.

Multi-Modal Optical Imaging of Cervix
Proflavine SolutionDRUG

Topical application of 0.01% proflavine solution applied for 1 minute to cervix after sites for biopsy have been identified during colposcopy.

Multi-Modal Optical Imaging of Cervix
Wide-Field Fluorescence ImagingPROCEDURE

Wide-field imaging in fluorescence mode performed during cervical colposcopy after topical proflavine solution applied.

Multi-Modal Optical Imaging of Cervix

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing colposcopy
  • years of age or older
  • Negative pregnancy test
  • Subjects must be willing and able to provide informed consent

You may not qualify if:

  • Patients under 18 years of age
  • Positive pregnancy test
  • Subjects unwilling and unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barretos Cancer Hospital

Barretos, 14784-400, Brazil

Location

Related Links

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Acetic Acid

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

AcetatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Kathleen Schmeler, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 9, 2015

Study Start

June 1, 2013

Primary Completion

October 7, 2021

Study Completion

October 7, 2021

Last Updated

October 12, 2021

Record last verified: 2021-10

Locations

BR(1)