Automated Method for Breast Cancer Detection

Stopped early · Not applicable

Conditions studied: Breast Cancer Diagnosis

In brief

Participants with suspicious breast lesions by mammography will undergo fine needle aspiration (FNA) under ultrasound guidance. The FNA will be read by the cytopathologist and analyzed in the breast cancer detection cartridge. All patients will receive standard of care (Ultrasound-guided core needle biopsy and diagnosis). We will also receive FNA collected from 60 patients with palpable lesions in South Africa and analyze them samples in our lab with the same method.

Key facts

Study ID

NCT03863522

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

116

Starts

2019-03-07

Expected to finish

2020-12-15

Last updated by the study team

2021-11-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patient must be female
• Patient must be 18 years of age or older
• Patient has been recommended for ultrasound core needle biopsy of a suspicious breast lesion

You may not qualify if…

• Patients may be excluded for any condition that in the opinion of the investigator may not make it safe to take part (e.g. certain medicines).

Where it is running

• Johns Hopkins Hospital Outpatient Center — Baltimore, Maryland, United States
• Johns Hopkins Medical Imaging at Green spring Station — Lutherville-Timonium, Maryland, United States

Full record on ClinicalTrials.gov

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