NEW YORK – ARTIDIS on Thursday said it has launched a clinical trial of the ARTIDIS device, which identifies malignant tissue via a nanomechanical signature, in breast cancer.
In the observational ARTIDIS Nanomechanical Generated Measurements for Early Lesions (ANGEL) trial, researchers will assess the performance of the nanomechanical signature in predicting tumor type, tumor aggressiveness, and neoadjuvant treatment response compared to histopathological assessment. The study will involve more than 2,700 participants with suspicious breast lesions who will undergo a breast biopsy procedure. The nanomechanical signature will be determined using ARTIDIS on fresh biopsy specimens or tissue from breast surgeries. The goal of the trial is to establish clinical utility of the device as a sensitive and specific diagnostic tool. Secondary outcome measures will include the ability of the device to predict aggressiveness and progression of cancer and to distinguish benign from malignant lesions.
ARTIDIS measures the nanomechanical signature by atomic force microscopy, which senses mechanical properties of the cells, to predict malignancy, aggressiveness, and treatment outcomes while preserving tissue integrity for other tests. The Basel, Switzerland-based company's ARTIDISNET platform then combines clinical data with the nanomechanical signature to further personalize the patient's treatment.
The first study sites to open will be at Baylor St. Luke's Medical Center and Harris Health Smith Clinic in Houston and Claraspital in Basel, Switzerland. The trial is expected to complete enrollment in 24 months and will include a 10-year follow-up period.
"The ANGEL study specifically addresses the key challenges of personalized diagnosis and treatment decision-making, particularly in the field of neoadjuvant therapy," ARTIDIS CEO Marija Plodinec said in a statement. "This clinical validation will enable us to deliver personalized diagnostics and treatment optimization to the patient bedside and help address and improve the entire patient journey."