ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• ARTIDIS as a sensitive diagnostic tool — Read-out on day 30
  Variable, indicating a correct classification of patients' core biopsy material as malignant with the Nanomechanical Phenotype measurement in comparison to histopathological assessment as gold-standard.
• ARTIDIS as a specific diagnostic tool — Read-out on day 30
  Variable, indicating a correct classification of patients' biopsy material as benign with the ARTIDIS Nanomechanical Phenotype measurement in comparison to histopathological assessment as gold-standard.

Trial sites (6)

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