Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens

Part of paid clinical trials in Tampa, Florida.

Sponsor
ARTIDIS AG
Study ID
NCT07542041
Status
Recruiting
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Conditions

  • Pancreatic Cancer
  • Pancreatic Ductal Adenocarcinoma (PDAC)
  • Pancreatic Lesions Located at the Body or the Tail
  • Pancreatic Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ARTIDIS ART-1 Device — 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 Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
May 31, 2028
Completion
May 31, 2030

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Pancreatic Cancer Cohort
    Participants with suspected pancreatic cancer undergoing standard-of-care biopsy or surgery, with additional tissue measurement using the ARTIDIS ART-1 device and prospective collection of clinical outcomes.

Primary Outcome Measure

Event-Free Survival (EFS) [ Time Frame: Every 3 months, up to 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Cappelle
[email protected]
8137454673
Saras A Cappelle, DO (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Moffitt Cancer Center· Tampa, FL

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