About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Participants unwilling to sign consent.
Participants under the age of 18.
Trial population
Participants will be accrued in medical clinics as determined by the local investigators and local research staff. Informed consent forms approved by each local IRB will be obtained by research staff from each site.
Trial design
Cohort
Prospective
Treatments tested in this trial
mHealth US-breast biopsy
Procedure/SurgeryDuring 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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