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)

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.

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Key information

Conditions

Breast Cancer Breast Cancer Female Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Lagos University Teaching Hospital, Idi-Araba, Lagos, Nigeria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mHealth US-breast biopsy

Procedure

During this study, women will undergo an US-guided breast biopsy by a radiologist instead of what is typically performed in Nigerian hospitals, which is either a blind biopsy or surgical excision. US-guided breast biopsy is the standard of care in the United States of America because the accuracy is better than blind biopsy and equal to surgical excision.

Primary outcomes

Number of successful US-guided breast biopsy

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Sutton, MD

CONTACT

[email protected]

646-888-5455

Yolana Bryce, MD

CONTACT

[email protected]

212-639-6530

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2027
First posted: Sep 30, 2022
Registry last updated: Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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