Nanomechanical testing for early breast lesions
ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions (ANGEL)
This study is testing a new method using tiny mechanical measurements to see if it can better predict the type and severity of breast tumors in patients with suspicious breast lesions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2706 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Artidis Ag Industry-sponsored |
| Locations | 5 sites (Dallas, Texas and 4 other locations) |
| Trial ID | NCT06085833 on ClinicalTrials.gov |
What this trial studies
This prospective, blinded, single-arm study evaluates the effectiveness of nanomechanical phenotype tests in predicting tumor type, aggressiveness, and treatment response in patients with suspicious breast lesions. Participants will undergo standard breast biopsy procedures, and the nanomechanical measurements will be compared to traditional histopathological assessments. The study aims to enhance diagnostic accuracy and treatment planning for breast cancer patients by utilizing innovative nanomechanical technology.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 and older who are referred for a breast biopsy due to suspicious lesions.
Not a fit: Patients with conditions that may render them unsuitable for the study, as determined by the investigator, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate and timely diagnoses of breast cancer, improving treatment outcomes for patients.
How similar studies have performed: While this approach is innovative, similar studies using advanced diagnostic techniques have shown promise in improving cancer detection and characterization.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Dallas, Texas and 4 other locations
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
- MD Anderson Cancer Clinic - Mays Clinic — Houston, Texas, United States (Recruiting)
- Hospital Universitario Vall d'Hebron — Barcelona, Barcelona, Spain (Recruiting)
- Claraspital — Basel, Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Alastair Thompson, MD — Baylor College of Medicine
- Study coordinator: Julia Ortega, DMSc, MHS, PA
- Email: julia.ortega@artidis.com
- Phone: 2404980176
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.