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ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions (ANGEL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06085833
Recruitment Status : Recruiting
First Posted : October 17, 2023
Last Update Posted : April 8, 2024
Sponsor:
Information provided by (Responsible Party):
ARTIDIS AG

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Diagnostic Test: Nanomechanical Phenotype Test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2706 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: The sponsor is blinded toward the pathological diagnosis of the participants.
Primary Purpose: Diagnostic
Official Title: ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions (ANGEL)
Actual Study Start Date : November 2, 2023
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : November 2035

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Human subjects requiring breast biopsy
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.
Diagnostic Test: Nanomechanical Phenotype 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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. ARTIDIS as an aid subtyping breast cancer [ Time Frame: Read-out on day 30 ]
    Diagnostic value (sensitivity) of subtype classification of invasive breast cancer with ARTIDIS Nanomechanical Phenotype Measurement compared to classical histopathology.

  2. ARTIDIS imminent progression test as an indicator of local & regional progression [ Time Frame: Read-out at 6 Months and annually up to 10 years ]
    Determine the ARTIDIS test's ability to detect local and regional progression at the time of diagnosis

  3. ARTIDIS imminent progression test as an indicator of distant progression [ Time Frame: Read-out at 6 Months and annually up to 10 years ]
    Determine the ARTIDIS test's ability to detect distant progression at the time of diagnosis

  4. ARTIDIS imminent aggressiveness rating as a predictor of the pathological treatment response for patients receiving Neoadjuvant Treatment (NAT). [ Time Frame: Read out at surgery ]
    Determine how well the ARTIDIS imminent aggressiveness rating predicts complete pathological treatment response at surgery for patients receiving Neoadjuvant Treatment.

  5. ARTIDIS imminent aggressiveness rating as a predictor of the radiological treatment response for patients receiving Neoadjuvant Treatment (NAT). [ Time Frame: Read out at surgery ]
    Determine how well the ARTIDIS imminent aggressiveness rating predicts radiological treatment response at the end of Neoadjuvant Treatment for patients receiving Neoadjuvant Treatment.

  6. ARTIDIS ARTIDIS aggressiveness rating as a predictor of local recurrence-free survival time. [ Time Frame: Read-out annually up to 10 years ]
    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.

  7. ARTIDIS ARTIDIS aggressiveness rating as a predictor of disease-free survival time. [ Time Frame: Read-out annually up to 10 years ]
    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.

  8. ARTIDIS ARTIDIS aggressiveness rating as a predictor of overall survival. [ Time Frame: Read-out annually up to 10 years ]
    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.

  9. ARTIDIS potential in distinguishing benign from malignant lesions with nanomechanical profiles in relation to different tissue sources. [ Time Frame: Read-out on day 30 ]
    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.).


Other Outcome Measures:
  1. Exploratory Objective 1: ARTIDIS as an aid for diagnostic efficacy for radiologically assessed breast lesions. [ Time Frame: Read-out on day 30 ]
    Diagnostic value (sensitivity) of BI-RADS 4 assessment in combination with Nanomechanical Phenotype Measurement or without Nanomechanical Phenotype Measurement with histopathological assessment as gold-standard.

  2. Exploratory Objective 2: ARTIDIS as an aid for radiologist to improve the reliability of BI-RADS classification. [ Time Frame: Read-out on day 30 ]
    Diagnostic value (sensitivity) of all BI-RADS assessments in combination with Nanomechanical Phenotype Measurement or without Nanomechanical Phenotype Measurement with histopathological assessment as gold-standard.

  3. Exploratory Objective 3: ARTIDIS potential in improving time to treatment initiation for patients with a malignant breast lesion in comparison to standard workflow. [ Time Frame: Read-out during the follow-up visits on month 6, month 12, and then annually up to 10 years ]
    Measurement of reduction of time to treatment initiation for patients with a high aggressive malignant lesion without ARTIDIS imminent aggressiveness measurement compared to time to treatment initiation with ARTIDIS imminent aggressiveness measurement via health care navigator interviews.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06085833


Contacts
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Contact: Anna Tsao, PhD 832-627-0578 anna.tsao@artidis.com
Contact: Marko Loparic, MD,PhD +41 61 633 29 93 Marko.Loparic@artidis.com

Locations
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United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Alastair Thompson, MD    713-798-1999    Alastair.Thompson@bcm.edu   
Principal Investigator: Alastair Thompson, MD         
Sponsors and Collaborators
ARTIDIS AG
Investigators
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Principal Investigator: Alastair Thompson, MD Baylor College of Medicine
Publications:
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Responsible Party: ARTIDIS AG
ClinicalTrials.gov Identifier: NCT06085833    
Other Study ID Numbers: ART-BrC-0102
First Posted: October 17, 2023    Key Record Dates
Last Update Posted: April 8, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by ARTIDIS AG:
Breast biopsy
breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases