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

Memorial Sloan Kettering Cancer Center (MSK) logo

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)

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

Trial contacts and locations

1

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Central trial contact

Adeleye Omisore, MD; Elizabeth Sutton, MD

Data sourced from clinicaltrials.gov

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