Clinical Study to Assess the Safety and Performance of Kenko Breast AI+ Medical Device as an Aid to Breast Cancer Diagnosis in Adult Women

Condition(s) studied

Investigational drug(s) / intervention(s)

Kenko Breast AI+: Kenko Breast AI+ is a medical software that processes breast magnetic resonance imaging (MRI) sequences to generate parametric maps of imaging biomarkers related to vascularization and cellularity. These maps assist radiologists in detecting, characterizing, and grading breast lesions, supporting diagnosis of malignancy and assessment of tumor aggressiveness. The software functions as a non-invasive imaging biomarker tool intended to complement, not replace, molecular and histopathological diagnostics. Kenko Breast AI+ is a Class IIb medical device. The assessment of MRI breast cases with Kenko Breast AI+ will be compared with the assessment of MRI breast cases without Kenko Breast AI+ as per routine clinical practice. The ground truth diagnosis will be established by routine clinical practice and may include a combination of clinical assessment, imaging results, tissue biopsy, and pathology reports.

Study summary

The goal of this observational study is to learn whether a new medical software tool called Kenko Breast AI+ can help healthcare professionals read breast magnetic resonance imaging (MRI) scans better to help diagnose breast cancer. The study includes adult women who may have breast cancer or who are being followed for the disease.

The main questions it aims to answer is:

* Does Kenko Breast AI+ help healthcare professionals find possible signs of breast cancer more accurately and efficiently when they read MRI scans?
* Does using the software cause any safety problems or software-related issues during the study?

Researchers will compare MRI readings done with the software to readings done without it.

Participants will attend their regularly scheduled breast MRI appointment. All diagnoses are based on standard medical care, not on the study software.

Eligibility

Primary outcome measure(s)

• The False Positive (FP), False Negatives (FN), True Positives (TP), and True Negatives (TN) rates. — Through MRI cases assessment during the study period (Months 1 to 11)
  The False Positive (FP), False Negatives (FN), True Positives (TP), and True Negatives (TN) rates expressed in integer numbers and in percentage for total results for assessment with and without the study device.
• Interpretation time. — Through MRI cases assessment during the study period (Months 1 to 11)
  The interpretation time, measured in minutes, for assessment with and without the study device.
• The occurrence of non-serious and serious device-related, or device procedures-related adverse events, and device deficiencies. — From enrollment through study completion (assessed up to 11 months)
  Safety events frequency.

Trial sites (1)

Other trials for the same condition