Breast CancerANGELNCT06085833
ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions
A study testing Nanomechanical Phenotype Test in people with Breast Cancer, run by ARTIDIS AG at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Nanomechanical Phenotype Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,706 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 2 Nov 2023to Nov 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Conditions that, in the investigator's opinion, might indicate that the subject is not suitable for the study.
Trial locations and contacts
6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 3 countries
United States4 sites, 4 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9020
Research Manager, 214-645-1568, Claire.Starcke@UTSouthwestern.edu
Basak Dogan, MD
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Alastair Thompson, MD, 7137981999, Alastair.Thompson@bcm.edu
Alastair Thompson, MD
- Recruiting
MD Anderson Cancer Clinic - Mays Clinic
Houston, Texas, 77030
Research Manager, MD, 713-745-8048, DWeber@mdanderson.org
Therese Bevers
- Recruiting
University of Washington
Seattle, Washington, 98195
Erin Fannon, Research Manager, 206.685.9770, ecarney@uw.edu
Principal Investigator Meghan Flanagan, MD
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Vall d'Hebron
Barcelona, Barcelona, 08035
Sonia Borao Arriazu, +34 93 489 30 00, sonia.borao@vhir.org
Vicente Peg, MD.PhD
About this study
Official title: ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions (ANGEL)
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.
Read the detailed description
Objective: To test the performance of nanomechanical phenotype tests in predicting tumor type, tumor aggressiveness, and neoadjuvant treatment response, compared to the gold standard of histopathological assessment on testing suspicious lesions.
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. Routine demographic, diagnostic and treatment data will be collected, as well as response evaluations. 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. All patients will be asked for written, informed consent for de-identified tissue and data collection on disease, histology characteristics, outcome, on disease related patent information, and patient reported outcomes.
The 2nd tissue core or representative core biopsies taken from the study subjects will be further investigated with the ARTIDIS platform and subsequently re-entered into the routine pathological analysis within the same day. Only two biopsies will be assessed per ART-1 device per day. One in the morning and one in the afternoon to ensure that the diagnostic biopsy can be reentered into the routine pathological analysis. The ARTIDIS measured biopsies will be marked to identify the orientation of the biopsy in the ART-1 device before re-entering the routine pathological analysis.
For malignant and benign lesions, follow up data will be extracted from the electronic medical record, as well as standard email/phone contacts performed by the study coordinator.
In order to assess the diagnostic performance of the proposed new method, it will be compared to the current gold standard. The participants cannot be randomized by study subjects with cancer vs. non cancer study subjects and will attempt to accrue a cohort representing a range of diagnostic outcomes in order to obtain a reasonable assessment of diagnostic performance.
Participants:
Patients with suspicious lesions who are referred for biopsy following routine mammography, ultrasound, MRI, and/or clinical evaluation.
Eligible subjects will be identified from each site's pool of patients by study investigators and the research team. Subjects will be asked to participate, interviewed and follow-up by explaining the possible benefit for future patients. Patients' advocates will participate in promotion of the study, as well as development of new strategies for recruitment if necessary.
Follow-up will be done by phone and/or email after consent according to study timelines, underlining future benefits of participation for other patients.
Outcome Measures:
The outcome measures will be the performance of nanomechanical phenotype tests in predicting tumor type, tumor aggressiveness, and neoadjuvant treatment response, compared to the gold standard of histopathological assessment.
Data Analysis:
Data will be analyzed using appropriate statistical methods to compare the performance of the nanomechanical phenotype test with the gold standard histopathological assessment. The full analysis set will consist of all patients, for whom both classifications of the core biopsy material are available, the one obtained from the ARTIDIS ART-1 device and the one from classical histopathological assessment.
Conclusion:
This study aims to determine the effectiveness of the nanomechanical phenotype test in predicting tumor type, tumor aggressiveness, and neoadjuvant treatment response.
- Conditions
- Breast Cancer
- Being tested
- Nanomechanical Phenotype Test
- Keywords
- Breast biopsy, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanomechanical Phenotype TestDiagnostic 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 group | Role | What they receive |
|---|---|---|
| Human subjects requiring breast biopsy | Other | 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. Receives: Diagnostic Test: Nanomechanical Phenotype Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
ARTIDIS as a sensitive diagnostic tool
Variable, indicating a correct classification of patients' core biopsy material as malignant with the Nanomechanical Phenotype measurement in comparison to histopathological assessment as gold-standard.
Measured: Read-out on day 30
ARTIDIS as a specific diagnostic tool
Variable, indicating a correct classification of patients' biopsy material as benign with the ARTIDIS Nanomechanical Phenotype measurement in comparison to histopathological assessment as gold-standard.
Measured: Read-out on day 30
Secondary outcomes (9)
ARTIDIS as an aid subtyping breast cancer
Diagnostic value (sensitivity) of subtype classification of invasive breast cancer with ARTIDIS Nanomechanical Phenotype Measurement compared to classical histopathology.
Measured: Read-out on day 30
ARTIDIS imminent progression test as an indicator of local & regional progression
Determine the ARTIDIS test's ability to detect local and regional progression at the time of diagnosis
Measured: Read-out at 6 Months and annually up to 10 years
ARTIDIS imminent progression test as an indicator of distant progression
Determine the ARTIDIS test's ability to detect distant progression at the time of diagnosis
Measured: Read-out at 6 Months and annually up to 10 years
ARTIDIS imminent aggressiveness rating as a predictor of the pathological treatment response for patients receiving Neoadjuvant Treatment (NAT).
Determine how well the ARTIDIS imminent aggressiveness rating predicts complete pathological treatment response at surgery for patients receiving Neoadjuvant Treatment.
Measured: Read out at surgery
ARTIDIS imminent aggressiveness rating as a predictor of the radiological treatment response for patients receiving Neoadjuvant Treatment (NAT).
Determine how well the ARTIDIS imminent aggressiveness rating predicts radiological treatment response at the end of Neoadjuvant Treatment for patients receiving Neoadjuvant Treatment.
Measured: Read out at surgery
ARTIDIS ARTIDIS aggressiveness rating as a predictor of local recurrence-free survival time.
Determine the ability of the ARTIDIS aggressiveness rating to discriminate between patients with a high risk of recurrence and those with a low risk, adjusted for the applied cancer treatment.
Measured: Read-out annually up to 10 years
ARTIDIS ARTIDIS aggressiveness rating as a predictor of disease-free survival time.
Determine the ability of the ARTIDIS aggressiveness rating to discriminate between patients with a high risk of suffering from further disease and those with a low risk, adjusted for the applied cancer treatment.
Measured: Read-out annually up to 10 years
ARTIDIS ARTIDIS aggressiveness rating as a predictor of overall survival.
Determine the ability of the ARTIDIS aggressiveness rating to discriminate between patients with a high risk of dying from any cause and those with a low risk, adjusted for the applied cancer treatment.
Measured: Read-out annually up to 10 years
ARTIDIS potential in distinguishing benign from malignant lesions with nanomechanical profiles in relation to different tissue sources.
Variable, indicating a correct classification of patients' biopsy material by ARTIDIS Nanomechanical Phenotype Measurement in comparison to Histopathology in relation to different tissue sources (e.g. CNB, VAB, MRI guided biopsy etc.).
Measured: Read-out on day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start2 Nov 2023
- Primary completionDec 2026 (estimated)
- Study completionNov 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,706 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ARTIDIS AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alastair Thompson, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085833
- Sponsor's protocol ID
- ART-BrC-0102
- Acronym
- ANGEL
- Status last verified
- Sep 2026
- First submitted
- 28 Apr 2023
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Plodinec M, Loparic M, Monnier CA, Obermann EC, Zanetti-Dallenbach R, Oertle P, Hyotyla JT, Aebi U, Bentires-Alj M, Lim RY, Schoenenberger CA. The nanomechanical signature of breast cancer. Nat Nanotechnol. 2012 Nov;7(11):757-65. doi: 10.1038/nnano.2012.167. Epub 2012 Oct 21.
PubMed 23085644
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions (ANGEL)
- ClinicalTrials.gov ID
- NCT06085833
- Acronym / sponsor ID
- ANGEL / ART-BrC-0102
- Conditions
- Breast Cancer
- Keywords
- Breast biopsy, breast cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,706 participants (estimated)
- Lead sponsor
- ARTIDIS AGIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Nov 2035 (estimated)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective: To test the performance of nanomechanical phenotype tests in predicting tumor type, tumor aggressiveness, and neoadjuvant treatment response, compared to the gold standard of histopathological assessment on testing suspicious lesions.
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. Routine demographic, diagnostic and treatment data will be collected, as well as response evaluations. 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. All patients will be asked for written, informed consent for de-identified tissue and data collection on disease, histology characteristics, outcome, on disease related patent information, and patient reported outcomes.
The 2nd tissue core or representative core biopsies taken from the study subjects will be further investigated with the ARTIDIS platform and subsequently re-entered into the routine pathological analysis within the same day. Only two biopsies will be assessed per ART-1 device per day. One in the morning and one in the afternoon to ensure that the diagnostic biopsy can be reentered into the routine pathological analysis. The ARTIDIS measured biopsies will be marked to identify the orientation of the biopsy in the ART-1 device before re-entering the routine pathological analysis.
For malignant and benign lesions, follow up data will be extracted from the electronic medical record, as well as standard email/phone contacts performed by the study coordinator.
In order to assess the diagnostic performance of the proposed new method, it will be compared to the current gold standard. The participants cannot be randomized by study subjects with cancer vs. non cancer study subjects and will attempt to accrue a cohort representing a range of diagnostic outcomes in order to obtain a reasonable assessment of diagnostic performance.
Participants:
Patients with suspicious lesions who are referred for biopsy following routine mammography, ultrasound, MRI, and/or clinical evaluation.
Eligible subjects will be identified from each site's pool of patients by study investigators and the research team. Subjects will be asked to participate, interviewed and follow-up by explaining the possible benefit for future patients. Patients' advocates will participate in promotion of the study, as well as development of new strategies for recruitment if necessary.
Follow-up will be done by phone and/or email after consent according to study timelines, underlining future benefits of participation for other patients.
Outcome Measures:
The outcome measures will be the performance of nanomechanical phenotype tests in predicting tumor type, tumor aggressiveness, and neoadjuvant treatment response, compared to the gold standard of histopathological assessment.
Data Analysis:
Data will be analyzed using appropriate statistical methods to compare the performance of the nanomechanical phenotype test with the gold standard histopathological assessment. The full analysis set will consist of all patients, for whom both classifications of the core biopsy material are available, the one obtained from the ARTIDIS ART-1 device and the one from classical histopathological assessment.
Conclusion:
This study aims to determine the effectiveness of the nanomechanical phenotype test in predicting tumor type, tumor aggressiveness, and neoadjuvant treatment response.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human subjects requiring breast biopsy | Other | Diagnostic Test: Nanomechanical Phenotype TestAll 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Conditions that, in the investigator's opinion, might indicate that the subject is not suitable for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nanomechanical Phenotype TestThe 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. | Diagnostic test | Human subjects requiring breast biopsy |
Primary outcome
ARTIDIS as a sensitive diagnostic tool
Time frame: Read-out on day 30
Variable, indicating a correct classification of patients' core biopsy material as malignant with the Nanomechanical Phenotype measurement in comparison to histopathological assessment as gold-standard.
ARTIDIS as a specific diagnostic tool
Time frame: Read-out on day 30
Variable, indicating a correct classification of patients' biopsy material as benign with the ARTIDIS Nanomechanical Phenotype measurement in comparison to histopathological assessment as gold-standard.
9 secondary outcomes
ARTIDIS as an aid subtyping breast cancer
Time frame: Read-out on day 30
ARTIDIS imminent progression test as an indicator of local & regional progression
Time frame: Read-out at 6 Months and annually up to 10 years
ARTIDIS imminent progression test as an indicator of distant progression
Time frame: Read-out at 6 Months and annually up to 10 years
ARTIDIS imminent aggressiveness rating as a predictor of the pathological treatment response for patients receiving Neoadjuvant Treatment (NAT).
Time frame: Read out at surgery
ARTIDIS imminent aggressiveness rating as a predictor of the radiological treatment response for patients receiving Neoadjuvant Treatment (NAT).
Time frame: Read out at surgery
ARTIDIS ARTIDIS aggressiveness rating as a predictor of local recurrence-free survival time.
Time frame: Read-out annually up to 10 years
ARTIDIS ARTIDIS aggressiveness rating as a predictor of disease-free survival time.
Time frame: Read-out annually up to 10 years
ARTIDIS ARTIDIS aggressiveness rating as a predictor of overall survival.
Time frame: Read-out annually up to 10 years
ARTIDIS potential in distinguishing benign from malignant lesions with nanomechanical profiles in relation to different tissue sources.
Time frame: Read-out on day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Background: PubMed 23085644Plodinec M, Loparic M, Monnier CA, Obermann EC, Zanetti-Dallenbach R, Oertle P, Hyotyla JT, Aebi U, Bentires-Alj M, Lim RY, Schoenenberger CA. The nanomechanical signature of breast cancer. Nat Nanotechnol. 2012 Nov;7(11):757-65. doi: 10.1038/nnano.2012.167. Epub 2012 Oct 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alastair Thompson, MD principal investigator
Baylor College of Medicine
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nanomechanical Phenotype Test in people with Breast Cancer, run by ARTIDIS AG at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Spain, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia Ortega, DMSc, MHS, PA (2404980176, julia.ortega@artidis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ARTIDIS as a sensitive diagnostic tool (time frame: Read-out on day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06085833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.