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.
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
Any condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study
Single group
ARTIDIS ART-1 Device
DeviceThe 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.
Event-Free Survival (EFS)
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
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.
Progression-Free Survival (PFS)
Progression-Free Survival is defined as the time from the start of treatment to disease progression or death from any cause. The analysis evaluates the association between study measurements and PFS.
Disease-Free Survival (DFS)
Disease-Free Survival is defined as the time from complete remission (e.g., after surgery) to disease recurrence or death from any cause. The analysis evaluates the association between study measurements and DFS.
Overall Survival (OS)
Overall Survival is defined as the time from the start of treatment to death from any cause. The analysis evaluates the association between study measurements and OS.
Radiological Response
Radiological response is assessed using standard imaging (e.g., CT or MRI) and categorized as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). The analysis evaluates the association between study measurements and radiological response.
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ARTIDIS AG
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborator
