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

Plain Language Summary

Simplified for easier understanding

This trial tests a new nanomechanical measurement technology to help detect whether breast tissue samples are cancerous at a very early stage. You may be eligible if... - You are 18 years or older - You understand and are willing to sign an informed consent form - You are already scheduled to have a breast biopsy for diagnostic reasons - Your overall health status (ECOG) is rated 0 to 3 You may NOT be eligible if... - Your doctor believes any personal health condition makes you unsuitable for the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.