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)

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05561842
• Other study ID #: 21-325
• Status: Recruiting
• Start date: September 21, 2022
• Est. completion date: September 21, 2027

Study information

• Verified date: January 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Elizabeth Sutton, MD
• Phone: 646-888-5455
• Email: suttone[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: September 21, 2027
• Est. primary completion date: September 21, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Female
• Breast Neoplasms

Intervention

Procedure:
• mHealth US-breast biopsy
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.

Locations

Country	Name	City	State
Nigeria	University Of Nigeria Teaching Hospital (UNTH) Ituku-Ozalla Enugu	Enugu
Nigeria	University College Hospital (Data Collection Only)	Ibadan	Oyo
Nigeria	Lagos University Teaching Hospital	Idi-Araba	Lagos
Nigeria	Lagos State University Teaching Hospital (Data Collection Only)	Ikeja
Nigeria	Obafemi Awolowo University Teaching Hospitals Complex (Data Collection Only)	Ile-Ife
Nigeria	University of Ilorin Teaching Hospitals	Ilorin
Nigeria	Federal Medical Centre Owo (Data Collection Only)	Owo	Ondo State
Nigeria	Olabisis Onabanjo University Teaching Hospital (Data Collection Only)	Sagamu	Ogun State
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Countries where clinical trial is conducted

United States,  Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of successful US-guided breast biopsy	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.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center