ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions

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

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.

Conditions2

Locations3 sites

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