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

NCT07580105 | Not Yet Recruiting

• 1 other identifier: PROSKENKOBreastAI+
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Breast Cancer Detection; Breast Cancer; Image Analysis; Breast MRI; Medical Imaging Software

Outcome Measures

Primary Outcomes (3)

• The False Positive (FP), False Negatives (FN), True Positives (TP), and True Negatives (TN) rates.

  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.

  Through MRI cases assessment during the study period (Months 1 to 11)

• Interpretation time.

  The interpretation time, measured in minutes, for assessment with and without the study device.

  Through MRI cases assessment during the study period (Months 1 to 11)

• The occurrence of non-serious and serious device-related, or device procedures-related adverse events, and device deficiencies.

  Safety events frequency.

  From enrollment through study completion (assessed up to 11 months)

Secondary Outcomes (9)

• Sensitivity, specificity, positive predictive value, negative predictive value, positive and negative likelihood ratios, and odds ratio for assessment with and without the study device.

  Through MRI cases assessment during the study period (Months 1 to 11)

• Descriptive breast lesion characteristics, including lesion breast, lesion location, lesion third, lesion type, lesion extension, Breast Imaging Reporting and Data System (BI-RADS) classification, and level of aggressiveness.

  Through MRI cases assessment during the study period (Months 1 to 11)

• Level of confidence in MRI assessment with and without the study device.

  Through MRI cases assessment during the study period (Months 1 to 11)

• Inter-reader concordance

  Before study initiation (5 training cases)

• Usability of the study device assessed by System Usability Scale (SUS)

  At study completion, after each reader has completed all MRI image assessments with and without the study device (Month 11)

Study Arms (1)

Participants

Adult women with suspected breast cancer or under surveillance for the disease

Device: Kenko Breast AI+

Interventions

Kenko Breast AI+ DEVICE

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.

Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prospective data will be collected from adult women with suspected or diagnosed breast cancer undergoing breast MRI as part of routine clinical care at Hospital Universitario del Vinalopó.

You may qualify if:

• Women with suspected breast cancer or under surveillance for the disease who have undergone MRI including perfusion (DCE-MRI), diffusion (DTI-MRI) and T2 sequences, performed for the purposes of:
• Staging,
• Assessment of response to neoadjuvant therapy,
• High suspicion of breast cancer, or
• Follow-up.
• For participants who have undergone MRI for follow-up purposes, prior breast MRI data collected at the most 12 months before the screening visit must be available.
• Women age 18 and older.
• Adult women able to understand the informed consent and participant information sheet and provide voluntary consent for the study.

You may not qualify if:

• Pregnant women.
• Individuals with incomplete or invalid perfusion, diffusion or T2 MRI sequences.
• Individuals for whom MRI is contraindicated or not feasible.

Sponsors & Collaborators

• Kenko Imalytics S.L.: lead
• MDx CRO (MED IVD HEALTHTECH S.L.): collaborator

Study Sites (1)

Hospital Universitario del Vinalopó

Elche, Alicante, 03293, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Raquel Laza Bulls

CONTACT

+34 697 70 84 87; raquel.laza@kenkoimalytics.com

Eric Aguado Sarrió

CONTACT

+34 669 953 839; eric@kenkoimalytics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)