RecruitingNot ApplicableNCT06085833

ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions

ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions (ANGEL)

Sponsor

ARTIDIS AG

Enrollment

2,706 participants

Start Date

Nov 2, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria1

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

Interventions

DIAGNOSTIC_TESTNanomechanical 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.