ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions
Sponsored by ARTIDIS AG
About this 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.
Objective: To test the performance of nanomechanical phenotype tests in predicting tumor type, tumor aggressiveness, and neoadjuvant treatment response, compared to the gold standard of histopathological assessment on testing suspicious lesions. Study Design: This is a multi-center, blinded, single-arm study designed to collect nanomechanical signature measurement data of biopsy material taken for clinical diagnostic purposes in subjects referred for breast biopsy. Routine demographic, diagnostic and treatment data will be collected, as well as response evaluations. Subjects with a benign biopsy will be followed for a maximum of 30 days, while subjects diagnosed with breast cancer will be kept in active, routine, clinical follow-up with information collected twice yearly for the first tw…
Where this study is enrolling (4)
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Baylor College of Medicine
Houston, Texas
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MD Anderson Cancer Clinic - Mays Clinic
Houston, Texas
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University of Texas Southwestern Medical Center
Dallas, Texas
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University of Washington
Seattle, Washington
Who can participate
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.
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Trial data sourced from ClinicalTrials.gov.