ClinicalTrials.gg
RecruitingNCT07542041ANoPsUpdated Aug 18, 2026

Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens

An interventional study of ARTIDIS ART-1 Device in Pancreatic Cancer, Pancreatic Neoplasms and Pancreatic Ductal Adenocarcinoma (PDAC), sponsored by ARTIDIS AG. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by ARTIDIS AG · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 1,852 studies in Pancreatic Neoplasms with a site in United States — 303 open to participants now, 475 under way, 25 of them phase 3. Pancreatic Neoplasms · United States.

Planned enrollment
175th of 1,575
200 · median 37
Started
2026
with 83 others
No phase
246 of 1,852
50 open now
Primary completion
2028-05
later than 329 of 474 live
Registered
1,802nd of 1,852
by date

Among the 1,852 studies in Pancreatic Neoplasms with a site in United States, this one is the 175th largest by planned enrollment of the 1,575 interventional ones that give a count, is one of 84 that started in 2026, is one of 246 with no phase, reaches primary completion later than 329 of the 474 other live ones, and was the 1,802nd registered.

Pancreatic Neoplasms

3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.

Browse Pancreatic Neoplasms studies →

Open to participants now

303 of the 1,852 studies in Pancreatic Neoplasms with a site in United States are open now. Recruiting first, the newest first:

298 more — sign in →

All 303 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 746 Pancreatic Neoplasms studies recruiting now, 479 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

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

Keywords

  • Atomic Force Microscopy
  • Neoadjuvant Therapy
  • Nanomechanical Profiling
  • NEO-Match
  • Pancreatic Ductal Adenocarcinoma
  • Pancreatic Cancer
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 years
  • Ability to understand and willingness to sign a written form
  • Clinical indication for fine needle (FNB) of a suspicious pancreatic lesion accessible for biopsy

Exclusion criteria

Exclusion Criteria:

  • Any condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study 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.

    Device: ARTIDIS ART-1 Device

Interventions

  • DeviceARTIDIS 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Every 3 months, up to 24 months

  2. 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.

    Time frame: Up to 24 months (assessed following surgery or biopsy as applicable)

Secondary outcomes

  1. Progression-Free Survival (PFS)

    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.

    Time frame: Up to 24 months (assessed at 12, 18, and 24 months)

  2. Disease-Free Survival (DFS)

    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.

    Time frame: Up to 24 months (assessed at 12, 18, and 24 months)

  3. Overall Survival (OS)

    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.

    Time frame: Up to 24 months (assessed at 12, 18, and 24 months)

  4. Radiological Response

    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.

    Time frame: After neoadjuvant therapy and prior to surgery

  5. Surgical Outcome (Resection Status

    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.

    Time frame: Post-surgery assessment

  6. Agreement With Histopathological Classification

    Agreement between study measurements and standard histopathological assessment in distinguishing malignant from non-malignant pancreatic lesions.

    Time frame: Approximately 30 days after pathology report availability

  7. Correlation With Molecular Subtypes

    Evaluation of the association between study measurements and pancreatic cancer subtypes as determined by standard pathological or molecular classification.

    Time frame: Approximately 30 days after pathology report availability

07

Study locations

1 of 1 sites recruiting
08

References and documents

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. PubMed 23085644 ↗

Related links

Individual participant data

Plan to share: No — 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for May 2028, 25 months after the start.

Of 430 interventional studies with no phase under Pancreatic Neoplasms, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 75. This study's planned 25 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 14, 2026
First posted
Apr 21, 2026
StartActual
Apr 17, 2026
Primary completionEst.
May 2028
CompletionEst.
May 2030
Last update
Aug 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07542041
Lead sponsor
ARTIDIS AG
Responsible party
Sponsor
First posted
Apr 21, 2026
Start date
Apr 17, 2026
Primary completion
May 2028 (estimated)
Completion
May 2030 (estimated)
Last update
Aug 18, 2026

Study contacts

Julia Ortega, DMSc, MHS, PA
Contact
julia.ortega@artidis.com
2404980176
Melissa Tongo
Contact
Melissa.Tongo@artidis.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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