Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma (PDAC), Pancreatic Lesions Located at the Body or the Tail, Pancreatic Neoplasms
Conditions
Keywords
Atomic Force Microscopy, Neoadjuvant Therapy, Nanomechanical Profiling, NEO-Match, Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer
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.
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
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.
Sponsors
ARTIDIS AG
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event-Free Survival (EFS) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation With Molecular Subtypes | 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. |
| Overall Survival (OS) | 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. |
| Radiological Response | 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. |
| Progression-Free Survival (PFS) | 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. |
| Surgical Outcome (Resection Status | 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. |
| Disease-Free Survival (DFS) | 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. |
| Agreement With Histopathological Classification | Approximately 30 days after pathology report availability | Agreement between study measurements and standard histopathological assessment in distinguishing malignant from non-malignant pancreatic lesions. |
Countries
United States
Contacts
CONTACTJulia Ortega, DMSc, MHS, PA
CONTACTMelissa Tongo
Outcome results
None listed