Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens

Condition(s) studied

Investigational drug(s) / intervention(s)

ARTIDIS ART-1 Device: The ARTIDIS ART-1 is an in vitro diagnostic device based on Atomic Force Microscopy (AFM) technology that measures the nanomechanical properties of fresh tissue samples. During standard-of-care biopsy or surgical procedures, an additional tissue sample may be collected when feasible and analyzed using the ART-1 device prior to routine histopathological assessment. The device measures nanomechanical characteristics of the tissue without direct contact with the patient. Following analysis, the tissue is returned to the standard clinical workflow for pathology evaluation. The use of the device does not influence clinical decision-making or patient treatment.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Event-Free Survival (EFS) — Every 3 months, up to 24 months
  Event-Free Survival (EFS) is defined as the time from initiation of anticancer therapy or study enrollment to the occurrence of an event, including disease progression, discontinuation of treatment for any reason, or death from any cause.
• Pathological Response — Up to 24 months (assessed following surgery or biopsy as applicable)
  Pathological response is assessed based on surgical or biopsy specimens and categorized as complete response, partial response, or no response. The analysis evaluates the association between study measurements and pathological response.

Trial sites (1)

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