Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens
ANoPs
1 other identifier
interventional
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pancreatic-cancer
Started Apr 2026
Typical duration for not_applicable pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2026
CompletedFirst Submitted
Initial submission to the registry
April 14, 2026
CompletedFirst Posted
Study publicly available on registry
April 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2030
April 21, 2026
April 1, 2026
2.1 years
April 14, 2026
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Event-Free Survival (EFS)
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
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 Outcomes (7)
Progression-Free Survival (PFS)
Up to 24 months (assessed at 12, 18, and 24 months)
Disease-Free Survival (DFS)
Up to 24 months (assessed at 12, 18, and 24 months)
Overall Survival (OS)
Up to 24 months (assessed at 12, 18, and 24 months)
Radiological Response
After neoadjuvant therapy and prior to surgery
Surgical Outcome (Resection Status
Post-surgery assessment
- +2 more secondary outcomes
Study Arms (1)
Pancreatic Cancer Cohort
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Any condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ARTIDIS AGlead
- H. Lee Moffitt Cancer Center and Research Institutecollaborator
Study Sites (1)
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Related Publications (1)
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
BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2026
First Posted
April 21, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2030
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
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.