Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06085833
NA

ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions

Sponsor: ARTIDIS AG

View on ClinicalTrials.gov

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.

Official title: ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions (ANGEL)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2706

Start Date

2023-11-02

Completion Date

2035-11

Last Updated

2026-03-12

Healthy Volunteers

No

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.

Locations (5)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

MD Anderson Cancer Clinic - Mays Clinic

Houston, Texas, United States

Hospital Universitario Vall d'Hebron

Barcelona, Barcelona, Spain

Claraspital

Basel, Basel, Switzerland