ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorARTIDIS AG

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Conditions that, in the investigator's opinion, might indicate that the subject is not suitable for the study.

Trial design

Treatments tested in this trial

  • Nanomechanical Phenotype Test

Treatment groups

2,706 Participants
are divided into 1 treatment group

Sponsors and collaborators