ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions

Conditions studied

Breast Cancer

About this study

This prospective, blinded, single-arm study aims to test the performance of nanomechanical phenotype in predicting tumor type, tumor aggressiveness, and neoadjuvant treatment response compared to the gold standard of histopathological assessment. The study involves patients with suspicious breast lesions who will undergo a breast biopsy procedure indicated by standard of care. The nanomechanical phenotype will be measured on the freshly obtained breast biopsies or tissue from breast surgeries.

Interventions

• Diagnostic Test: Nanomechanical Phenotype Test — The ARTIDIS ART-1 device is an in-vitro diagnostic device based on Atomic Force Microscope (AFM) technology. The ART-1 device uses a probe to measure the nanomechanical phenotype of tissue components. ARTIDIS nanomechanical phenotype measurements are performed on fresh tissue after it is collected via biopsy or resection.

Primary outcomes

• ARTIDIS as a sensitive diagnostic tool (Read-out on day 30)
• ARTIDIS as a specific diagnostic tool (Read-out on day 30)

Eligibility information

Study locations

• University of Texas Southwestern Medical Center, Dallas, Texas 75390-9020 United States
• Baylor College of Medicine, Houston, Texas 77030 United States
• MD Anderson Cancer Clinic - Mays Clinic, Houston, Texas 77030 United States
• University of Washington, Seattle, Washington 98195 United States
• Hospital Universitario Vall d'Hebron, Barcelona, Barcelona 08035 Spain
• Claraspital, Basel, Basel CH-4058 Switzerland