ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions

Recruiting now · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT06085833

Run by

ARTIDIS AG

People needed

2706

Starts

2023-11-02

Expected to finish

2035-11-01

Last updated by the study team

2026-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged ≥ 18 years
• Ability to understand and the willingness to sign a written informed consent.
• Indication for breast biopsy for diagnostic purposes
• ECOG performance status of 0 to 3.

You may not qualify if…

• Conditions that, in the investigator's opinion, might indicate that the subject is not suitable for the study.

Where it is running

• University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• Baylor College of Medicine — Houston, Texas, United States (enrolling)
• MD Anderson Cancer Clinic - Mays Clinic — Houston, Texas, United States (enrolling)
• Hospital Universitario Vall d'Hebron — Barcelona, Barcelona, Spain (enrolling)
• Claraspital — Basel, Basel, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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