ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions
Recruiting · NCT06085833 · Interventional (participants receive a specific treatment) · Lead sponsor: ARTIDIS AG
View the official record on ClinicalTrials.gov →Interventions studied
Nanomechanical Phenotype Test
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
5 locations listed across 1 US state.
- 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