Pancreatic CancerANoPsNCT07542041
Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens
A study testing ARTIDIS ART-1 Device in people with Pancreatic Cancer and Pancreatic Neoplasms, run by ARTIDIS AG at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Neoplasms, Pancreatic Ductal Adenocarcinoma (PDAC)
- What is being tested?
- ARTIDIS ART-1 Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2026to May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Melissa Tongo contact
United States1 site, 1 recruiting
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Cappelle
8137454673, saras.cappelle@moffitt.org
About this study
Official title: 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:
Read more
- 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.
- Conditions
- Pancreatic Cancer, Pancreatic Neoplasms, Pancreatic Ductal Adenocarcinoma (PDAC), Pancreatic Lesions Located at the Body or the Tail
- Being tested
- ARTIDIS ART-1 Device
- Keywords
- Atomic Force Microscopy, Neoadjuvant Therapy, Nanomechanical Profiling, NEO-Match, Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARTIDIS ART-1 DeviceDevice
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 group | Role | What they receive |
|---|---|---|
| Pancreatic Cancer Cohort | Experimental | 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. Receives: Device: ARTIDIS ART-1 Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 24 months (assessed following surgery or biopsy as applicable)
Secondary outcomes (7)
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.
Measured: Up to 24 months (assessed at 12, 18, and 24 months)
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.
Measured: Up to 24 months (assessed at 12, 18, and 24 months)
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.
Measured: Up to 24 months (assessed at 12, 18, and 24 months)
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.
Measured: After neoadjuvant therapy and prior to surgery
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.
Measured: Post-surgery assessment
Agreement With Histopathological Classification
Agreement between study measurements and standard histopathological assessment in distinguishing malignant from non-malignant pancreatic lesions.
Measured: Approximately 30 days after pathology report availability
Correlation With Molecular Subtypes
Evaluation of the association between study measurements and pancreatic cancer subtypes as determined by standard pathological or molecular classification.
Measured: Approximately 30 days after pathology report availability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start17 Apr 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ARTIDIS AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- H. Lee Moffitt Cancer Center and Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542041
- Sponsor's protocol ID
- ART-PaC-0301
- Acronym
- ANoPs
- Status last verified
- Aug 2026
- First submitted
- 14 Apr 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens (ANoPs)
- ClinicalTrials.gov ID
- NCT07542041
- Acronym / sponsor ID
- ANoPs / ART-PaC-0301
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- ARTIDIS AGIndustry (pharma, biotech, devices)
- Collaborators
- H. Lee Moffitt Cancer Center and Research Institute
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatic Cancer Cohort | Experimental | Device: ARTIDIS ART-1 DeviceParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Any condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARTIDIS ART-1 DeviceThe 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. | Device | Pancreatic Cancer Cohort |
Primary outcome
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.
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Background: PubMed 23085644Plodinec 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melissa Tongo contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARTIDIS ART-1 Device in people with Pancreatic Cancer and Pancreatic Neoplasms, run by ARTIDIS AG at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia Ortega, DMSc, MHS, PA (2404980176, julia.ortega@artidis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-Free Survival (EFS) (time frame: Every 3 months, up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07542041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.