Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ARTIDIS ART-1 Device.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer, Pancreatic Neoplasms, Pancreatic Ductal Adenocarcinoma (PDAC), Pancreatic Lesions Located at the Body or the Tail. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens (ANoPs)
Overview
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.
Detailed description
Pancreatic ductal adenocarcinoma (PDAC) is associated with poor prognosis due to late diagnosis, early metastasis, and limited response to therapy. Current clinical, imaging, and molecular approaches have limitations in characterizing disease behavior and treatment response, particularly in the neoadjuvant setting. Additional methods to better understand disease characteristics in routine clinical practice are of interest.
This study evaluates the ARTIDIS nanomechanical profiling platform and its derived NEO-Match® score in pancreatic cancer. The ARTIDIS ART-1 system is an in vitro diagnostic device based on Atomic Force Microscopy (AFM) technology that measures the nanomechanical properties of fresh tissue samples. These measurements characterize structural and functional properties of tumor tissue and the surrounding microenvironment.
This is a prospective, single-arm clinical study enrolling adult patients (≥18 years) referred for biopsy of a suspected malignant pancreatic lesion. The study is conducted at Moffitt Cancer Center and is integrated into the standard clinical workflow. Participation does not alter, delay, or influence standard-of-care diagnostic or therapeutic procedures.
During routine biopsy or surgical resection, one additional research-use tissue sample may be collected when feasible. This sample will be analyzed using the ART-1 device prior to standard histopathological assessment. Following measurement, the tissue will be returned to the clinical workflow for routine pathology evaluation. Additional tissue samples may be collected during follow-up biopsies or surgery, when available.
The study will assess the relationship between nanomechanical measurements obtained using the ARTIDIS system and clinical data, including imaging findings, histopathology, treatment information, and patient outcomes. The primary objective is to evaluate the association between the NEO-Match® score and outcomes of neoadjuvant therapy, including event-free survival and pathological response. Secondary objectives include evaluation of associations with progression-free survival, overall survival, radiological response, and surgical outcomes, as well as assessment of agreement with standard histopathological classification of pancreatic lesions.
Participants will continue to receive all treatments according to standard of care. Clinical data, including imaging, pathology reports, treatment details, and outcomes, will be collected prospectively. Participants will be followed every three months for up to two years.
This study is non-interventional and is considered minimal risk, as all procedures are part of standard clinical care and the ARTIDIS device does not have direct contact with patients. The results of this study are intended to support further evaluation of nanomechanical tissue measurements in the clinical setting.
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 tis
Primary outcome measures
- Event-Free Survival (EFS) [Time frame: Every 3 months, up to 24 months]
- Pathological Response [Time frame: Up to 24 months (assessed following surgery or biopsy as applicable)]
Secondary outcome measures (7)
- Progression-Free Survival (PFS) [Time frame: Up to 24 months (assessed at 12, 18, and 24 months)]
- Disease-Free Survival (DFS) [Time frame: Up to 24 months (assessed at 12, 18, and 24 months)]
- Overall Survival (OS) [Time frame: Up to 24 months (assessed at 12, 18, and 24 months)]
- Radiological Response [Time frame: After neoadjuvant therapy and prior to surgery]
- Surgical Outcome (Resection Status [Time frame: Post-surgery assessment]
- Agreement With Histopathological Classification [Time frame: Approximately 30 days after pathology report availability]
- Correlation With Molecular Subtypes [Time frame: Approximately 30 days after pathology report availability]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Moffitt Cancer Center — Tampa
Publications
- Plodinec M, Loparic M, Monnier CA, Obermann EC, Zanetti-Dallenbach R, Oertle P, Hyotyla JT, Aebi U, Bentires-Alj M, Lim RY, Schoenenberger CA. The nanomechanical signature of breast cancer. Nat Nanotechnol. 2012 Nov;7(11):757-65. doi: 10.1038/nnano.2012.167. Epub 2012 Oct 21. PMID 23085644
Identifiers
NCT: NCT07542041 · ART-PaC-0301