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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Breast Cancer

Treatments: Procedure: US-guided breast biopsy; Other: Ultrasound-guided breast biopsy training program

Study type: Interventional

Funder types: Other

Identifiers

NCT04501419

18-114

ERC/2019/10/05

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Trained radiologists

Experimental group

Description:

Trainers will successfully train Nigerian radiologists

Treatment:

Other: Ultrasound-guided breast biopsy training program

Patients with a suspicious breast mass

Experimental group

Description:

Women that present to the hospital with a suspicious breast mass

Treatment:

Procedure: US-guided breast biopsy