Automated Method for Breast Cancer Detection

Johns Hopkins Medicine

Status: Terminated

Conditions: Breast Cancer Diagnosis

Treatments: Device: Cancer Detection cartridge; Procedure: Fine needle aspiration

Study type: Interventional

Funder types: Other

Identifiers

NCT03863522

J18138

IRB00172441 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

116 participants in 1 patient group

Fine Needle Aspiration

Other group

Description:

Participants will receive fine needle aspiration (FNA) later read by the cytopathologist and the cartridge. All patients will receive standard of care (Ultrasound-guided core needle biopsy and diagnosis).

Treatment:

Procedure: Fine needle aspiration

Device: Cancer Detection cartridge