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

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMemorial Sloan Kettering Cancer Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • US-guided breast biopsy

    Procedure/Surgery

    During 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 intervention

    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

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Trained radiologistsExperimental treatment 1 intervention
Group B: Patients with a suspicious breast massExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months

Secondary outcomes

1

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

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Memorial Sloan Kettering Cancer Center

Lead sponsor

Obafemi Awolowo University Teaching Hospital

Collaborator