Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria (Mobile Health: Technology and Outcomes in Low and Middle-Income Countries)

Recruiting

• Conditions: Breast Cancer Female; Breast Cancer
• Interventions: Procedure: mHealth US-breast biopsy

• Registration Number: NCT05561842
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to train Nigerian radiologists to perform ultrasound-guided breast biopsies. Researchers will use mHealth devices to create a sustainable and practical way of training radiologists in Nigeria to perform and clinically implement US-guided breast biopsies into their practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-21
• Study First Submitted: 2022-09-27
• Study First Submitted QC: 2022-09-27
• Study First Posted: 2022-09-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-20
• Primary Completion: 2026-09-21
• Study Completion: 2027-09-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 900

Inclusion Criteria

• Age 18 and older female.
• Breast ultrasound demonstrating a solid mass that is suspicious for cancer, which would typically undergo either a blind biopsy or surgical excision at the Nigerian hospital where the patient is seeking diagnosis.

Exclusion Criteria

• Participants unwilling to sign consent.
• Participants under the age of 18.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with a solid mass on breast ultrasound	mHealth US-breast biopsy	Participants will have a solid mass on breast ultrasound that is suspicious for breast cancer.

Primary Outcome Measures

Name	Time	Method
Number of successful US-guided breast biopsy	1 year	Trainees will be evaluated using a passing criterion of 80% on a validated test that assesses competency based on the The Ottawa Surgical Competency Operating Room Evaluation (O-Score). There are 8 variables rated on a scale of 1-5. A trainee will be given a passing grade if the responses on all 8 variables are 4 or 5 and this is achieved in at least 80% of the unsupervised simulation and patient biopsies.

Trial Locations

Locations (8)

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Lagos University Teaching Hospital; 🇳🇬 Idi-Araba, Lagos, Nigeria

Olabisis Onabanjo University Teaching Hospital (Data Collection Only); 🇳🇬 Sagamu, Ogun State, Nigeria

Federal Medical Centre Owo (Data Collection Only); 🇳🇬 Owo, Ondo State, Nigeria

University College Hospital (Data Collection Only); 🇳🇬 Ibadan, Oyo, Nigeria

University Of Nigeria Teaching Hospital (UNTH) Ituku-Ozalla Enugu; 🇳🇬 Enugu, Nigeria

Obafemi Awolowo University Teaching Hospitals Complex (Data Collection Only); 🇳🇬 Ile-Ife, Nigeria

University of Ilorin Teaching Hospitals; 🇳🇬 Ilorin, Nigeria