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ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions
Sponsor: ARTIDIS AG
Summary
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.
Official title: ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions (ANGEL)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2706
Start Date
2023-11-02
Completion Date
2035-11
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (5)
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
MD Anderson Cancer Clinic - Mays Clinic
Houston, Texas, United States
Hospital Universitario Vall d'Hebron
Barcelona, Barcelona, Spain
Claraspital
Basel, Basel, Switzerland