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ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions

NCT06085833 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2706

Last updated 2026-04-17

No results posted yet for this study

Summary

This prospective, blinded, single-arm study aims to test the performance of nanomechanical phenotype in predicting tumor type, tumor aggressiveness, and neoadjuvant treatment response compared to the gold standard of histopathological assessment. The study involves patients with suspicious breast lesions who will undergo a breast biopsy procedure indicated by standard of care. The nanomechanical phenotype will be measured on the freshly obtained breast biopsies or tissue from breast surgeries.

Conditions

Interventions

DIAGNOSTIC_TEST

Nanomechanical Phenotype Test

The ARTIDIS ART-1 device is an in-vitro diagnostic device based on Atomic Force Microscope (AFM) technology. The ART-1 device uses a probe to measure the nanomechanical phenotype of tissue components. ARTIDIS nanomechanical phenotype measurements are performed on fresh tissue after it is collected via biopsy or resection.

Sponsors & Collaborators

  • ARTIDIS AG

    lead INDUSTRY

Principal Investigators

  • Alastair Thompson, MD · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-02
Primary Completion
2026-12-31
Completion
2035-11-30

Countries

  • United States
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06085833 on ClinicalTrials.gov