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ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions

Sponsor: ARTIDIS AG • ClinicalTrials.gov ID: NCT06085833

Registry updated: 2026-09-22
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Description

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

  • Nanomechanical Phenotype Test (Diagnostic 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.

Eligibility criteria

Inclusion Criteria: * Patients aged ≥ 18 years * Ability to understand and the willingness to sign a written informed consent. * Indication for breast biopsy for diagnostic purposes * ECOG performance status of 0 to 3. Exclusion Criteria: * Conditions that, in the investigator's opinion, might indicate that the subject is not suitable for the study.

Conditions

Breast Cancer

Locations

  • 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
  • University of Washington — Seattle, Washington, United States
  • Hospital Universitario Vall d'Hebron — Barcelona, Barcelona, Spain
  • Claraspital — Basel, Basel, Switzerland
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record