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Tablet-Based Mobile Health Ultrasound for Point-of-Care Breast Cancer Diagnosis in Nigeria
Trial Status: active
This study aims to train Nigerian radiologists to perform ultrasound (US)-guided breast biopsies on women that present to the hospital with a suspicious breast mass. US-guided breast biopsy is the standard of care in other countries but not in Nigeria because the radiologists don’t have the required skills. Therefore, breast cancer is commonly diagnosed by either blind biopsy (sticking a needle into the breast mass by palpation) or surgical excision. US-guided biopsy is more accurate than blind biopsy and its accuracy is equivalent to surgery, but it is less expensive and less morbid. Training Nigerian radiologist may increase the number of Nigerian radiologists performing appropriate and affordable US-guided breast biopsies.
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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05561842.
I. Train and evaluate the performance of thirteen The African Research Group for Oncology (ARGO) Nigerian radiologists in performing ultrasound (US)-guided breast biopsies using the competency-based mobile (m)Health training program.
II. To evaluate complication rates from the procedure.
III. To evaluate pathological concordance.
SECONDARY OBJECTIVES:
I. To estimate the positive predictive value (PPV) and negative predictive value (NPV) of the intervention at the biopsy level in patients with suspicious findings.
II. To evaluate stage at diagnosis; treatment; and time between first medical presentation and diagnosis.
III. To compare clinical characteristics between patients with a benign versus malignant diagnosis based on the results of their mHealth US biopsy.
OUTLINE: This is an observational study. Participants are assigned to 1 of 2 cohorts.
COHORT I: Radiologists undergo a competency-based mobile health ultrasound-guided breast biopsy-training program.
COHORT II: Patients undergo US-guided breast biopsy by a radiologist.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMemorial Sloan Kettering Cancer Center
