Abstract CT273: Unique multicenter trial design to investigate ARTIDIS nanomechanical generated measurements for early breast lesions (ANGEL)
Authors: Sepulveda Karla A. , Roark Ashley , Dhamne Sagar , Nagi Chandandeep , Marin Ivan , Tabish Iqbal , Nizzero Sara , Gachechiladze Mariam , Appenzeller Tobias , Oertle Philipp , Loparic Marko , Hilsenbeck Susan G. , Plodinec Marija , Thompson Alastair 
Published: April 2024

Abstract
Background:  The conventional diagnosis of breast cancer followed by molecular subtyping for therapy selection is a lengthy process and associated with patient and clinician anxiety. Efficient, bedside approaches are desirable to drive fast diagnosis and early planning of clinical management. This clinical trial (NCT06085833) tackles the novel concept of automated and reliable tissue diagnostics (ARTIDIS) based on the measurement of nanomechanical signature of fresh clinical biopsies from patients with breast lesions. This study is based on our previous single center clinical study (Basel NANO) where tissue nanomechanical signature can: 1) reliably distinguish benign and malignant breast lesions, 2) predict the presence of metastatic disease based on imminent aggressiveness rating and 3) predict the response to neoadjuvant chemotherapy from baseline biopsies. The current study aims to prospectively validate the efficacy of ARTIDIS system as an aid to diagnosis, assessment of breast cancer prognosis and prediction of therapy response, particularly in the context of neoadjuvant therapy (Natira).
Methods:  A cohort of 2,705 patients with breast lesions, who are clinically indicated for core needle biopsy (CNB) are being enrolled, from diverse ethnic and socioeconomic backgrounds. Single fresh CNB will be transferred into tissue preservation buffer and measured by ARTIDIS device within 1-3 hours to collect thousands of nanomechanical measurements. Undisrupted CNB will be fixed and returned to standard diagnostic workflow, remaining unaltered for downstream assessments. Nanomechanical measurement data are prospectively analyzed in a blind manner before the collection of histopathology and follow up clinical data. The primary endpoint of the study is to validate ARTIDIS potential in diagnosis of breast lesions (benign vs malignant), secondary endpoints address whether nanomechanical signature can differentiate subtypes of breast cancer, associate with clinical outcome and guide treatment decisions in NAT setting. Follow up data will be collected regularly up to 10 years after patient enrollment.
Results: The multicenter ANGEL study is a prospective validation of the NANO (University Hospital Basel, Switzerland) - first ever performed clinical study which investigated the diagnostic, prognostic, and predictive value of tissue nanomechanical signature in patients with breast cancer. The ANGEL study takes advantage of ARTIDIS non-disruptive technology and is fully integrated into routine clinical workflow. The study started enrollment in 11/02/2023, and is expected to complete by 2025. The seamless integration of ARTIDIS within the standard clinical settings, its automatization, bedside implementation, and the lack of additional burden to patients enables effective reach of a diverse population through local hospitals and communities.
Conclusion: This study presents the first of its kind as a direct prospective, multicenter- based translation of the tissue nanomechanical signature into clinical settings. This unique trial design allows the prospective development of ARTIDIS as an aid to diagnosis, prognosis and therapy optimization in patients with breast cancer. The innovative trial design of this study may also further the development of strategies to increase reach to underrepresented communities.
Citation Format: Karla A. Sepulveda, Ashley Roark, Sagar Dhamne, Chandandeep Nagi, Ivan Marin, Iqbal Tabish, Sara Nizzero, Mariam Gachechiladze, Tobias Appenzeller, Philipp Oertle, Marko Loparic, Susan G. Hilsenbeck, Marija Plodinec, Alastair Thompson. Unique multicenter trial design to investigate ARTIDIS nanomechanical generated measurements for early breast lesions (ANGEL) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(7_Suppl):Abstract nr CT273.