ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions

Part of paid clinical trials in Dallas, Texas.

Sponsor
ARTIDIS AG
Study ID
NCT06085833
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Nov 2, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Nov 30, 2035

Study Design

Enrollment
2,706 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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.

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390-9020
Research Manager
[email protected]
214-645-1568
Basak Dogan, MD (PRINCIPAL_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
Alastair Thompson, MD
[email protected]
7137981999
Alastair Thompson, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer Clinic - Mays ClinicHoustonTexas77030
Research Manager, MD
[email protected]
713-745-8048
Therese Bevers (PRINCIPAL_INVESTIGATOR)

Find similar trials in Dallas, TX

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Texas Southwestern Medical Center· Dallas, TXBaylor College of Medicine· Houston, TXMD Anderson Cancer Clinic - Mays Clinic· Houston, TX

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