This study is testing a new diagnostic tool called the ARTIDIS ART-1 device. This device uses a special technology (Atomic Force Microscope or AFM) to measure the physical properties (nanomechanical phenotype) of breast tissue. The goal is to see how well these measurements can predict the type and aggressiveness of breast tumors, and how they might respond to treatment, compared to standard lab tests. You may be able to join if you are at least 18 years old, need a breast biopsy, and are able to understand and sign a consent form. The study will look at whether ARTIDIS is a sensitive and specific tool for diagnosis, with results expected around 30 days after the tissue is collected.

Study design

This is a multi-center, blinded, single-arm study planning to enroll 2706 participants. It is designed to collect nanomechanical signature measurements from biopsy material.

What's involved

You would undergo a breast biopsy as part of your standard medical care. Tissue samples from this biopsy will be used for the study. If your biopsy is benign, you will be followed for up to 30 days. If you are diagnosed with breast cancer, you will have routine follow-up for up to ten years.

Compensation

Not stated in the trial record.

Follow-up

If your biopsy is benign, you will be followed for a maximum of 30 days. If you are diagnosed with breast cancer, you will be followed twice yearly for the first two years and annually for years three to ten.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.