Recruiting

NEO-Match® Test

Sponsor:

ARTIDIS AG

Code:

NCT07542041

Conditions

Pancreatic Cancer

Pancreatic Neoplasms

Pancreatic Ductal Adenocarcinoma (PDAC)

Pancreatic Lesions Located at the Body or the Tail

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ARTIDIS ART-1 Device

Study Details

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.

Conditions

Pancreatic Cancer

Pancreatic Neoplasms

Pancreatic Ductal Adenocarcinoma (PDAC)

Pancreatic Lesions Located at the Body or the Tail

Study ID

NCT07542041

Start date

Apr 17, 2026

Status verified date

Aug, 2026

Completion date

May, 2030

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

ARTIDIS 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.

Primary outcome measure

  • Event-Free Survival (EFS) [ Time Frame: Every 3 months, up to 24 months ]
  • Pathological Response [ Time Frame: Up to 24 months (assessed following surgery or biopsy as applicable) ]

Central Contacts and Locations

Central contacts

Julia Ortega, DMSc, MHS, PA

2404980176julia.ortega@artidis.com

Melissa Tongo

Melissa.Tongo@artidis.com

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

8137454673saras.cappelle@moffitt.org

Principal Investigator:

Saras A Cappelle, DO

More Information

Sponsor

ARTIDIS AG

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by ARTIDIS AG on 2026-08-18.