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RECRUITING
NCT07542041
NA

Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens

Sponsor: ARTIDIS AG

View on ClinicalTrials.gov

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.

Official title: Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens (ANoPs)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-04-17

Completion Date

2030-05

Last Updated

2026-08-18

Healthy Volunteers

No

Interventions

DEVICE

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.

Locations (1)

Moffitt Cancer Center

Tampa, Florida, United States