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ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions

ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions (ANGEL)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies, MRI scans, Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Study Design: This is a multi-center, blinded, single-arm study designed to collect nanomechanical signature measurement data of biopsy material taken for clinical diagnostic purposes in subjects referred for breast biopsy."
  • "Subjects with a benign biopsy will be followed for a maximum of 30 days, while subjects diagnosed with breast cancer will be kept in active, routine, clinical follow-up with information collected twice yearly for the first two years and annually for years three to ten."
  • "Intermediate treatment biopsies or tissue samples from surgery may be collected at participating sites where they are performed routinely as standard of care (SOC)."
  • "All patients referred to participating study sites for a core needle or vacuum-assisted breast biopsy may be eligible for this study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether measuring tiny physical features of breast tissue can predict the type of tumor, how aggressively it may grow, and how it responds to treatment before surgery. It compares these results with standard tissue testing under a microscope. It is for adults with suspicious breast changes who need a breast biopsy, a procedure that removes tissue for testing.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Able to understand the study and willing to sign a written consent form.
  • Need a breast biopsy to help make a diagnosis.
  • Have an ECOG activity score of 0 to 3, ranging from fully active to needing help with daily care and spending much of the day in bed or a chair.

Who can't join

  • Have a condition that the study doctor thinks makes you unsuitable for the study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (4)

TX

WA