Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens

Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens (ANoPs)

The goal of this clinical study is to evaluate whether the NEO-Match® test, based on ARTIDIS nanomechanical profiling technology, can help predict treatment outcomes and improve clinical decision-making in patients with suspected pancreatic cancer undergoing biopsy.

The main questions this study aims to answer are:

• Can the NEO-Match® test predict how patients respond to neoadjuvant (pre-surgical) treatment for pancreatic cancer?
• How well does the NEO-Match® test detect malignant pancreatic lesions compared to standard histopathological assessment?

This is a prospective, single-arm study. Researchers will compare results from the NEO-Match® test with standard clinical outcomes, imaging findings, and pathology results to evaluate its predictive and diagnostic performance.

Participants will:

• Undergo a standard-of-care pancreatic biopsy or surgical procedure
• Provide an additional biopsy sample for research analysis using the ARTIDIS ART-1 device
• Continue to receive standard treatment and care, which is not influenced by the study
• Have clinical data, imaging results, and treatment outcomes collected
• Be followed every 3 months for up to 2 years

The study does not involve experimental treatment or changes to standard medical care. The information collected may help improve future diagnosis, prognosis, and treatment selection for patients with pancreatic cancer.

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.

Inclusion Criteria:

• Age ≥ 18 years
• Ability to understand and willingness to sign a written informed consent form
• Clinical indication for fine needle biopsy (FNB) of a suspicious pancreatic lesion accessible for biopsy

Exclusion Criteria:

• Any condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study