ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorARTIDIS AG
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Conditions that, in the investigator's opinion, might indicate that the subject is not suitable for the study.
Trial design
Design model
Single group
Treatments tested in this trial
Nanomechanical Phenotype Test
Diagnostic 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.
Treatment groups
2,706 Participants
are divided into 1 treatment groupGroup A: Human subjects requiring breast biopsyOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Read-out on day 302
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.
Time frame
Read-out on day 30Secondary outcomes
1
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.
Time frame
Read-out on day 302
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
Time frame
Read-out at 6 Months and annually up to 10 years3
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
Time frame
Read-out at 6 Months and annually up to 10 years4
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.
Time frame
Read out at surgeryOther outcomes
1
Exploratory Objective 1: ARTIDIS as an aid for diagnostic efficacy for radiologically assessed breast lesions.
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.
Time frame
Read-out on day 302
Exploratory Objective 2: ARTIDIS as an aid for radiologist to improve the reliability of BI-RADS classification.
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.
Time frame
Read-out on day 303
Exploratory Objective 3: ARTIDIS potential in improving time to treatment initiation for patients with a malignant breast lesion in comparison to standard workflow.
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.
Time frame
Read-out during the follow-up visits on month 6, month 12, and then annually up to 10 years Source ClinicalTrials.gov