ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions

NCT06085833 | Recruiting

• 1 other identifier: ART-BrC-0102
• Study Type: interventional
• Target: 2,706
• Locations: 3 countries
• Sites: 5

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

Keywords

Breast biopsy; breast cancer

Outcome Measures

Primary Outcomes (2)

• ARTIDIS as a sensitive diagnostic tool

  Variable, indicating a correct classification of patients' core biopsy material as malignant with the Nanomechanical Phenotype measurement in comparison to histopathological assessment as gold-standard.

  Read-out on day 30

• ARTIDIS as a specific diagnostic tool

  Variable, indicating a correct classification of patients' biopsy material as benign with the ARTIDIS Nanomechanical Phenotype measurement in comparison to histopathological assessment as gold-standard.

  Read-out on day 30

Secondary Outcomes (9)

• ARTIDIS as an aid subtyping breast cancer

  Read-out on day 30

• ARTIDIS imminent progression test as an indicator of local & regional progression

  Read-out at 6 Months and annually up to 10 years

• ARTIDIS imminent progression test as an indicator of distant progression

  Read-out at 6 Months and annually up to 10 years

• ARTIDIS imminent aggressiveness rating as a predictor of the pathological treatment response for patients receiving Neoadjuvant Treatment (NAT).

  Read out at surgery

• ARTIDIS imminent aggressiveness rating as a predictor of the radiological treatment response for patients receiving Neoadjuvant Treatment (NAT).

  Read out at surgery

Other Outcomes (3)

• Exploratory Objective 1: ARTIDIS as an aid for diagnostic efficacy for radiologically assessed breast lesions.

  Read-out on day 30

• Exploratory Objective 2: ARTIDIS as an aid for radiologist to improve the reliability of BI-RADS classification.

  Read-out on day 30

• Exploratory Objective 3: ARTIDIS potential in improving time to treatment initiation for patients with a malignant breast lesion in comparison to standard workflow.

  Read-out during the follow-up visits on month 6, month 12, and then annually up to 10 years

Study Arms (1)

Human subjects requiring breast biopsy

OTHER

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.

Diagnostic Test: Nanomechanical Phenotype Test

Interventions

Nanomechanical Phenotype Test DIAGNOSTIC_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.

Human subjects requiring breast biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• ARTIDIS AG: lead

Study Sites (5)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9020, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

MD Anderson Cancer Clinic - Mays Clinic

Houston, Texas, 77030, United States

RECRUITING

Hospital Universitario Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

Claraspital

Basel, Basel, CH-4058, Switzerland

RECRUITING

Related Publications (1)

• Plodinec M, Loparic M, Monnier CA, Obermann EC, Zanetti-Dallenbach R, Oertle P, Hyotyla JT, Aebi U, Bentires-Alj M, Lim RY, Schoenenberger CA. The nanomechanical signature of breast cancer. Nat Nanotechnol. 2012 Nov;7(11):757-65. doi: 10.1038/nnano.2012.167. Epub 2012 Oct 21.

  PMID: 23085644 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Alastair Thompson, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Ortega, DMSc, MHS, PA

CONTACT

2404980176; julia.ortega@artidis.com

Marko Loparic, MD,PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The sponsor is blinded toward the pathological diagnosis of the participants.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: October 17, 2023
• Study Start: November 2, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): November 1, 2035
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

ES (1); CH (1); US (3)