About this trial
The purpose of this study is to train Nigerian radiologists to perform ultrasound-guided breast biopsies on women that present to the hospital with a suspicious breast mass. Before performing biopsies on patients, the Nigerian radiologists will have already successfully completed a competency-based mobile health ultrasound-guided breast biopsy-training program. This program, developed by experts in Nigeria and the United States of America, certifies that they have the skills required to safely perform these biopsies on patients.
Eligibility criteria
This trial accepts 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 design
Parallel
Treatments tested in this trial
US-guided breast biopsy
Procedure/SurgeryDuring this study, women with 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.
Ultrasound-guided breast biopsy training program
Other interventionThis program, developed by experts in Nigeria and the United States of America, certifies that they have the skills required to safely perform these biopsies on patients
Treatment groups
Trial outcomes
Primary outcomes
Accuracy of US-guided breast biopsy in Nigeria compared to reference standard surgical excision
US-guided breast biopsies accuracy measurements will be reported using surgical pathology as the reference standard. Specifically we will report accuracy, positive predictive value, negative predictive value, sensitivity and specificity.
Secondary outcomes
Complication rates from US-guided breast biopsy compared to reference values reported in the literature.
To determine if the complication rate of US-guided breast biopsies performed by the trained Nigerian radiologists is equivalent to reference values reported in the literature.
Sponsors and contacts
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Memorial Sloan Kettering Cancer Center
Lead sponsor
Obafemi Awolowo University Teaching Hospital
Collaborator