ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions

(ANGEL Trial)

Overseen By Tobias Appenzeller

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ARTIDIS AG

Disqualifiers: Others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

2706 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Alastair Thompson, MD

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

Inclusion Criteria

You are capable of understanding and consent to sign a legally-binding document.

You are being recommended for a breast biopsy to diagnose a condition.

You have a performance status ranging from 0 to 3 on the Eastern Cooperative Oncology Group scale.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Biopsy and Initial Assessment

Participants undergo a breast biopsy procedure and nanomechanical phenotype measurement

1 day

1 visit (in-person)

Follow-up

Participants with benign lesions are followed for 30 days, while those with cancer are followed up to 10 years

10 years

Twice yearly for the first 2 years, then annually

Treatment Details

Participant Groups

Group I: Human subjects requiring breast biopsy Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

ARTIDIS AG

Lead Sponsor

Trials

1

Recruited

2,700+