Recruiting

Ultrasound-Guided Biopsy

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05561842

Conditions

Breast Cancer

Breast Cancer Female

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

mHealth US-breast biopsy

Study Details

Brief summary:

The purpose of this study is to train Nigerian radiologists to perform ultrasound-guided breast biopsies. Researchers will use mHealth devices to create a sustainable and practical way of training radiologists in Nigeria to perform and clinically implement US-guided breast biopsies into their practice.

Conditions

Breast Cancer

Breast Cancer Female

Study ID

NCT05561842

Start date

Sep 21, 2022

Status verified date

Oct, 2025

Completion date

Sep 21, 2027

Anticipated

Primary completion date

Sep 21, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

900 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants with a solid mass on breast ultrasound

Participants will have a solid mass on breast ultrasound that is suspicious for breast cancer.

Interventions

mHealth US-breast biopsy

During this study, women will 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.

Primary outcome measure

  • Number of successful US-guided breast biopsy [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Elizabeth Sutton, MD

646-888-5455suttone@mskcc.org

Yolana Bryce, MD

212-639-6530brycey@mskcc.org

Locations

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Elizabeth Sutton, MD

646-888-5455

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Keywords

  • breast ultrasound
  • breast cancer
  • breast biopsy
  • breast cancer diagnosis
  • 21-325
  • Memorial Sloan Kettering Cancer Center

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2025-10-14.