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Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens

NCT07542041

RecruitingNA

Sponsor: ARTIDIS AG

Conditions: Pancreatic Cancer, Pancreatic Neoplasms, Pancreatic Ductal Adenocarcinoma (PDAC), Pancreatic Lesions Located at the Body or the Tail

Interventions: ARTIDIS ART-1 Device

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Tampa, Florida, United States