Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens (ANoPs)

April 14, 2026 updated by: ARTIDIS AG

Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens (ANoPs)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Contact:
          • Cappelle
        • Contact:
        • Principal Investigator:
          • Saras A Cappelle, DO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-Free Survival (EFS)
Time Frame: Every 3 months, up to 24 months
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.
Every 3 months, up to 24 months
Pathological Response
Time Frame: Up to 24 months (assessed following surgery or biopsy as applicable)
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.
Up to 24 months (assessed following surgery or biopsy as applicable)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Up to 24 months (assessed at 12, 18, and 24 months)
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.
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)
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.
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)
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.
Up to 24 months (assessed at 12, 18, and 24 months)
Radiological Response
Time Frame: After neoadjuvant therapy and prior to surgery
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.
After neoadjuvant therapy and prior to surgery
Surgical Outcome (Resection Status
Time Frame: Post-surgery assessment
Surgical outcome is assessed by resection status and categorized as R0 (complete resection with negative margins) or R1 (microscopic residual tumor). The analysis evaluates the association between study measurements and surgical outcomes.
Post-surgery assessment
Agreement With Histopathological Classification
Time Frame: Approximately 30 days after pathology report availability
Agreement between study measurements and standard histopathological assessment in distinguishing malignant from non-malignant pancreatic lesions.
Approximately 30 days after pathology report availability
Correlation With Molecular Subtypes
Time Frame: Approximately 30 days after pathology report availability
Evaluation of the association between study measurements and pancreatic cancer subtypes as determined by standard pathological or molecular classification.
Approximately 30 days after pathology report availability

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARTIDIS AG

Collaborators

H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Plodinec M, Loparic M, Monnier CA, et al. The nanomechanical signature of breast cancer. Nature Nanotechnology. 2012;7(11):757-765. https://doi.org/10.1038/nnano.2012.167

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2030

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ART-PaC-0301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to privacy, regulatory, and confidentiality considerations. Although study data are de-identified, the dataset includes detailed clinical, imaging, and tissue-related information that may carry a risk of re-identification. In addition, the data are subject to institutional policies, data protection regulations (including HIPAA), and sponsor confidentiality requirements. Therefore, access to individual-level data is restricted to authorized study personnel.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Neoplasms

Clinical Trials on ARTIDIS ART-1 Device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe