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Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens (ANoPs)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
Moffitt Cancer Center
RECRUITING
Tampa
Contact Information
Primary
Julia Ortega, DMSc, MHS, PA
julia.ortega@artidis.com
2404980176
Backup
Melissa Tongo
Melissa.Tongo@artidis.com
Time Frame
Start Date: 2026-04
Estimated Completion Date: 2030-05
Participants
Target number of participants: 200
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: ARTIDIS AG
Collaborators: H. Lee Moffitt Cancer Center and Research Institute

This content was sourced from clinicaltrials.gov

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