NCT06085833 ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions
| NCT ID | NCT06085833 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ARTIDIS AG |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,706 participants |
| Start Date | 2023-11-02 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,706 participants in total. It began in 2023-11-02 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Alastair Thompson, MD
PRINCIPAL INVESTIGATOR
Baylor College of Medicine
Frequently Asked Questions
Who can join the NCT06085833 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06085833 currently recruiting?
Yes, NCT06085833 is actively recruiting participants. Contact the research team at julia.ortega@artidis.com for enrollment information.
Where is the NCT06085833 trial being conducted?
This trial is being conducted at Dallas, United States, Houston, United States, Houston, United States, Barcelona, Spain and 1 additional location.
Who is sponsoring the NCT06085833 clinical trial?
NCT06085833 is sponsored by ARTIDIS AG. The principal investigator is Alastair Thompson, MD at Baylor College of Medicine. The trial plans to enroll 2,706 participants.
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