ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions (ANGEL)
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Baylor College of Medicine
RECRUITING
Houston
MD Anderson Cancer Clinic - Mays Clinic
RECRUITING
Houston
Other Locations
Spain
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
Switzerland
Claraspital
RECRUITING
Basel
Contact Information
Primary
Tobias Appenzeller
tobias.appenzeller@artidis.com
+41 61 633 29 93
Backup
Marko Loparic, MD,PhD
Marko.Loparic@artidis.com
+41 61 633 29 95
Time Frame
Start Date: 2023-11-02
Estimated Completion Date: 2035-11
Participants
Target number of participants: 2706
Treatments
Other: Human subjects requiring breast biopsy
All patients referred to participating study sites for a core needle or vacuum-assisted breast biopsy are eligible for this study. Upon consent, a diagnostic biopsy will be measured by the sponsor's device before returning to the standard of care pathway.
Related Therapeutic Areas
Sponsors
Leads: ARTIDIS AG