Artidis has announced the commencement of its worldwide multicentre clinical trial, ARTIDIS Nanomechanical Generated Measurements for Early Lesions (ANGEL), for breast cancer care.
The trial is led by Olga Keith Wiess surgery chair and Baylor College of Medicine Breast Cancer Surgery section chief Dr Alastair Thompson and seeks to transform breast cancer care by leveraging tissue nanomechanics for improved diagnostics and treatment optimisation.
It intends to validate the clinical utility of the Nanomechanical Signature by assessing the ARTIDIS bedside device’s capacity to assess biopsies and precisely detect breast cancer subtypes.
The device integrates into standard-of-care workflows and offers a quick solution to detect malignant tissue and preserve tissue integrity for subsequent evaluations.
Besides, the advanced ARTIDISNET incorporates clinical achievement data with the Nanomechanical Signature to deliver an integrated approach to personalised patient diagnostics and treatment.
The study will also focus on predicting treatment response and clinical outcomes, particularly in the context of neoadjuvant therapy (NAT).
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Its goal is to enrol more than 2,700 patients, providing in-depth knowledge about various breast cancer subtypes.
Baylor St Luke’s Medical Center and the Harris Health Smith Clinic in Houston, Texas, are the initial recruitment sites for this worldwide study.
In Europe, the first centre will be the Claraspital in Basel, Switzerland, where Dr Rosanna Zanetti will serve as the lead site investigator.
Artidis CEO Dr Marija Plodinec said: “The ANGEL study specifically addresses the key challenges of personalised diagnosis and treatment decision-making, particularly in the field of neoadjuvant therapy.”
The NANO study, conducted at the University Hospital Basel, confirmed the clinical utility of the Nanomechanical Signature in differentiating malignant and benign breast lesions in 545 individuals.