Recruiting

Nanomechanical Phenotype

Sponsor:

ARTIDIS AG

Code:

NCT06085833

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nanomechanical Phenotype Test

Study Details

Brief 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.

Conditions

Breast Cancer

Study ID

NCT06085833

Start date

Nov 2, 2023

Status verified date

Apr, 2026

Completion date

Nov, 2035

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

2706 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

Nanomechanical Phenotype Test

The ARTIDIS ART-1 device is an in-vitro diagnostic device based on Atomic Force Microscope (AFM) technology. The ART-1 device uses a probe to measure the nanomechanical phenotype of tissue components. ARTIDIS nanomechanical phenotype measurements are performed on fresh tissue after it is collected via biopsy or resection.

Primary outcome measure

  • ARTIDIS as a sensitive diagnostic tool [ Time Frame: Read-out on day 30 ]
  • ARTIDIS as a specific diagnostic tool [ Time Frame: Read-out on day 30 ]

Central Contacts and Locations

Central contacts

Julia Ortega, DMSc, MHS, PA

2404980176julia.ortega@artidis.com

Marko Loparic, MD,PhD

+41 61 633 29 95Marko.Loparic@artidis.com

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390-9020

Contacts

Research Manager

214-645-1568Claire.Starcke@UTSouthwestern.edu

Principal Investigator:

Basak Dogan, MD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Alastair Thompson, MD

7137981999Alastair.Thompson@bcm.edu

Principal Investigator:

Alastair Thompson, MD

MD Anderson Cancer Clinic - Mays Clinic

Recruiting

Houston, Texas, United States, 77030

Contacts

Research Manager, MD

713-745-8048DWeber@mdanderson.org

Principal Investigator:

Therese Bevers

More Information

Sponsor

ARTIDIS AG

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Keywords

  • Breast biopsy
  • breast cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ARTIDIS AG on 2026-04-17.