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ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions

Recruiting

ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions (ANGEL)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

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

About the study

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.

What is being tested

Sponsor: ARTIDIS AG · Participants: 2,706 · Started: Nov 2, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT06085833

Locations in the U.S.

TexasUniversity of Texas Southwestern Medical Center, Dallas
Baylor College of Medicine, Houston
MD Anderson Cancer Clinic - Mays Clinic, Houston
WashingtonUniversity of Washington, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.