Low-cost Imaging Technology for Global Prevention of Cervical Cancer

Low-cost Mobile Colposcopy and Confocal Imaging for Global Prevention of Cervical Cancer

Cervical cancer remains the first or second leading cause of cancer death among women in many low-and middle-income countries. Cervical cancer prevention programs in low-resource settings are hampered by a lack of personnel with appropriate clinical expertise, lack of pathology services, and lack of associated infrastructure. There is an urgent need for appropriate diagnostic tools to enable accurate screening and diagnosis in low-resource settings. The purpose of this study is to develop and validate a low-cost Multimodal Mobile Colposcope (MMC) for global cervical cancer prevention programs. This new device will combine the imaging capabilities of a mobile colposcope with the microscopic imaging capabilities of a fiber-optic confocal imaging probe.

Study Overview

• Status: Recruiting
• Conditions: Cervical Intraepithelial Neoplasia
• Intervention / Treatment: Device: Multimodal Mobile Colposcope (MMC)

• Study Type: Interventional
• Enrollment (Anticipated): 1060
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Júlio César P Resende, MD, PhD; Phone Number: 7086 +55 (17) 3321-6600; Email: julio.possati@uol.com.br
• Study Contact Backup: Name: Mila P Salcedo, MD, PhD; Phone Number: +1-832-316-3774; Email: mpsalcedo@mdanderson.org

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
      • Recruiting
      • Irmandade Santa Casa de Misericordia de Porto Alegre
      • Contact: Mila P Salcedo, MD, PhD
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784-400
      • Recruiting
      • Barretos Cancer Hospital
      • Contact: Júlio César P Resende, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women >25 years of age;
• Women undergoing colposcopy due to abnormal cervical screening or follow-up for a history of dysplasia;
• Women of childbearing potential must have a negative urine or blood pregnancy test;
• Ability to understand and willingness to provide informed consent by signing specific Informed Consent Document.

Exclusion Criteria:

• Women under 25 years of age;
• Women who have undergone hysterectomy with removal of the cervix;
• Women with known allergy to proflavine or acriflavine;
• Women who are pregnant or nursing at the time of enrollment;
• Incapacitated women or in vulnerable situations or who are not willing to give consent;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental group - MMC; Imaging of study participants will be performed during the colposcopy examination. The mobile colposcope and the confocal imaging probe, together referred to as the Multimodal Mobile Colposcope (MMC), will be used to image and/or record videos the cervix. Cervical biopsies will be performed using biopsy forceps per standard protocols.	Device: Multimodal Mobile Colposcope (MMC); Women referred for colposcopy due to abnormal cervical screening or follow-up for a history of dysplasia will be recruited into the experimental group of the study. Imaging of study participants will take place during the colposcopy examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Develop and validate a Multimodal Mobile Colposcope (MMC)	Image data will be used as a training set to develop and refine image analysis algorithms. Multimodal Mobile Colposcope will be compared with colposcopic impression considering clinical performance (sensitivity, specificity, positive and negative predictive values, and area under the Receiver Operating Characteristic (ROC) curve)	Day 1 - at the colposcopy day

Collaborators and Investigators

• Sponsor: Barretos Cancer Hospital
• Collaborators: M.D. Anderson Cancer Center; William Marsh Rice University; Irmandade Santa Casa de Misericórdia de Porto Alegre

Publications and helpful links

General Publications

• Hunt B, Fregnani JHTG, Brenes D, Schwarz RA, Salcedo MP, Possati-Resende JC, Antoniazzi M, de Oliveira Fonseca B, Santana IVV, de Macedo Matsushita G, Castle PE, Schmeler KM, Richards-Kortum R. Cervical lesion assessment using real-time microendoscopy image analysis in Brazil: The CLARA study. Int J Cancer. 2021 Jul 15;149(2):431-441. doi: 10.1002/ijc.33543. Epub 2021 Apr 3.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 20, 2021
• Primary Completion (ANTICIPATED): April 3, 2025
• Study Completion (ANTICIPATED): December 3, 2025

Study Registration Dates

• First Submitted: October 4, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (ACTUAL): October 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: cervical intraepithelial neoplasia; image analysis; cancer prevention
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma in Situ; Neoplasms; Cervical Intraepithelial Neoplasia
• Other Study ID Numbers: 38969820.9.1001.5437

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No