Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens

Pancreatic ductal adenocarcinoma (PDAC) is associated with poor prognosis due to late

diagnosis, early metastasis, and limited response to therapy. Current clinical, imaging,

and molecular approaches have limitations in characterizing disease behavior and

treatment response, particularly in the neoadjuvant setting. Additional methods to better

understand disease characteristics in routine clinical practice are of interest.

This study evaluates the ARTIDIS nanomechanical profiling platform and its derived

NEO-Match® score in pancreatic cancer. The ARTIDIS ART-1 system is an in vitro diagnostic

device based on Atomic Force Microscopy (AFM) technology that measures the nanomechanical

properties of fresh tissue samples. These measurements characterize structural and

functional properties of tumor tissue and the surrounding microenvironment.

This is a prospective, single-arm clinical study enrolling adult patients (≥18 years)

referred for biopsy of a suspected malignant pancreatic lesion. The study is conducted at

Moffitt Cancer Center and is integrated into the standard clinical workflow.

Participation does not alter, delay, or influence standard-of-care diagnostic or

therapeutic procedures.

During routine biopsy or surgical resection, one additional research-use tissue sample

may be collected when feasible. This sample will be analyzed using the ART-1 device prior

to standard histopathological assessment. Following measurement, the tissue will be

returned to the clinical workflow for routine pathology evaluation. Additional tissue

samples may be collected during follow-up biopsies or surgery, when available.

The study will assess the relationship between nanomechanical measurements obtained using

the ARTIDIS system and clinical data, including imaging findings, histopathology,

treatment information, and patient outcomes. The primary objective is to evaluate the

association between the NEO-Match® score and outcomes of neoadjuvant therapy, including

event-free survival and pathological response. Secondary objectives include evaluation of

associations with progression-free survival, overall survival, radiological response, and

surgical outcomes, as well as assessment of agreement with standard histopathological

classification of pancreatic lesions.

Participants will continue to receive all treatments according to standard of care.

Clinical data, including imaging, pathology reports, treatment details, and outcomes,

will be collected prospectively. Participants will be followed every three months for up

to two years.

This study is non-interventional and is considered minimal risk, as all procedures are

part of standard clinical care and the ARTIDIS device does not have direct contact with

patients. The results of this study are intended to support further evaluation of

nanomechanical tissue measurements in the clinical setting.