The nanomechanical signature of breast cancer.
Marija Plodinec, Marko Loparic, Christophe A Monnier...
https://pubmed.ncbi.nlm.nih.gov/23085644/Actively Recruiting
Led by ARTIDIS AG · Updated on 2026-04-21
200
Participants Needed
1
Research Sites
104 weeks
Total Duration
Researchers are investigating the use of the NEO-Match4 test, which utilizes ARTIDIS nanomechanical profiling technology, to predict treatment outcomes and improve clinical decisions in patients suspected of having pancreatic cancer undergoing biopsy. This study aims to determine if the NEO-Match4 test can forecast how patients respond to pre-surgical treatment and how well it detects cancerous pancreatic lesions compared to standard pathology. The study is prospective and single-arm, focusing on adults referred for biopsy of suspicious pancreatic lesions. Participants will undergo standard pancreatic biopsy or surgery as part of their usual care. During these procedures, an extra tissue sample may be taken for analysis with the ARTIDIS ART-1 device, which measures the nanomechanical properties of fresh tissue without direct patient contact. After analysis, the tissue is returned for routine pathology evaluation. The study integrates this testing into normal clinical workflows without altering treatment plans. Throughout the study, clinical data including imaging, pathology, treatments, and outcomes will be collected. Participants will be followed every three months for up to two years to monitor event-free survival, pathological response, progression-free survival, overall survival, and other clinical outcomes. This non-interventional study poses minimal risk and aims to assess how well the nanomechanical measurements correlate with standard diagnostic and treatment results for pancreatic cancer.
CONDITIONS
Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens
J
Julia Ortega, DMSc, MHS, PA
M
Melissa Tongo
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ARTIDIS AG
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | ARTIDIS ART-1 Device | Current Standard Pathology |
|---|---|---|
| What it is | An in vitro diagnostic device using Atomic Force Microscopy to measure nanomechanical properties of freshly collected pancreatic tissue samples after biopsy or surgery. | The established laboratory assessment of tissue samples through microscopic pathological examination to determine diagnosis and guide treatment. |
| Role in the trial | Tissue samples collected during routine clinical procedures are analyzed using the ARTIDIS ART-1 device before returning to standard pathology workflow. The device evaluation does not alter clinical decisions or patient treatment. | Samples are processed and examined by pathologists according to established procedures for tissue diagnosis. Pathology findings guide clinical management. |
| Primary use | To investigate whether nanomechanical measurements can help classify pancreatic cancer specimens and contribute to improved diagnostic accuracy compared to routine methods. | To deliver definitive diagnosis of pancreatic lesions based on microscopic analysis of tissue structure, cellular morphology, and relevant markers. |
| How it is performed | A fresh tissue sample collected during biopsy or surgery is placed on the ARTIDIS ART-1 device platform, measured using AFM technology, and then returned for pathology processing. | Samples are fixed, processed, sliced, stained, and examined under the microscope by pathologists as per routine lab procedure. |
| Evidence status | Evidence from prior cancer studies shows AFM-based nanomechanical profiling can distinguish malignant from benign tissue in breast cancer, but published results for pancreatic cancer are not yet available. The current trial aims to establish diagnostic performance in pancreatic lesions. | Histopathology remains international standard for tissue diagnosis in pancreatic cancer with well-established accuracy and published performance in multiple large studies and guidelines. |
| Important limitations | The ARTIDIS ART-1 device has not been clinically validated for pancreatic cancer diagnosis. Performance may depend on the quality and type of tissue sample. Limited evidence exists beyond breast cancer studies. | Histopathology can be affected by sampling error, tissue quality, and interpretive variability. Occasionally diagnosis may be inconclusive or require additional tests. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During routine biopsy or surgical procedure
Participants undergo standard-of-care biopsy or surgery where an additional tissue sample is collected for analysis using the ARTIDIS ART-1 device. This device measures nanomechanical properties of the tissue without direct contact with the participant. The tissue sample is then returned to routine pathology evaluation.
1 to 2 visits depending on biopsy or surgery schedule
Duration - Up to 24 months
Participants are followed every three months for up to two years to collect clinical data including imaging, pathology reports, treatment details, and outcomes.
Quarterly visits every 3 months for up to 2 years
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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Marija Plodinec, Marko Loparic, Christophe A Monnier...
https://pubmed.ncbi.nlm.nih.gov/23085644/ARTIDIS AG
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsor