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

Clinical Pre-Market, Observational, Prospective, Blinded, Controlled, Single-Center Study to Assess the Safety and Performance of Kenko Breast AI+ Medical Device as an Aid to Breast Cancer Diagnosis in Adult Women

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Kenko Breast AI+

Detailed Description

This clinical investigation is a study designed to assess the safety, diagnostic performance, and usability of Kenko Breast AI+, a medical device software intended to support breast cancer diagnosis using breast MRI.

The study is includes adult women who undergo breast MRI as part of routine clinical care for suspected breast cancer or oncological surveillance. The study does not alter standard clinical management and does not introduce additional diagnostic or therapeutic procedures.

Independent radiologist readers assess MRI examinations either with or without assistance from Kenko Breast AI+. Each MRI case is evaluated once per reader during the first assessment phase and reassessed after a washout period using the alternate method. The sequence of assessments and reader allocation is randomized. Reader assessments are compared with a reference diagnosis established according to routine clinical practice.

MRI datasets acquired during routine care are reviewed for technical quality, pseudonymized at the study site, and uploaded to both the investigational software platform and the site's picture archiving and communication system (PACS). Readers access the assigned cases through the appropriate platform according to randomization. After study completion, readers complete usability evaluations of the investigational device.

The study is conducted in accordance with ISO 14155:2020, Good Clinical Practice, and applicable regulatory requirements (EU Medical Device Regulation 2017/745). Quality assurance measures include site qualification and initiation, staff training, predefined workflows, and documented delegation of responsibilities.

Monitoring activities are performed by an independent sponsor-appointed monitor and include on-site and remote visits, verification of protocol compliance, review of safety reporting, and assessment of data accuracy. Study close-out procedures confirm completeness and proper archiving of study documentation. Audits and regulatory inspections may be conducted as required.

Study data are recorded in validated electronic data capture systems using predefined case report forms. Automated and manual data checks are applied to ensure completeness, consistency, and plausibility. Discrepancies or missing values are resolved through a formal query process, and all data modifications are documented in audit trails. Source data verification is performed during monitoring visits by comparing electronic case report form entries with original source documents.

A total of 200 participants are included to provide adequate precision for estimating diagnostic performance parameters. The sample size is based on assumptions of sensitivity and specificity greater than 85% and a predefined acceptable margin of error. The planned enrollment exceeds that of many published diagnostic imaging studies and is considered sufficient for the study objectives.

MRI cases or lesions without an established reference diagnosis are excluded from primary diagnostic performance analyses. Reasons for missing data are documented and summarized. Descriptive comparisons are performed to assess potential bias. Invalid or technically inadequate MRI datasets are excluded according to predefined criteria.

Analyses are conducted according to a predefined statistical analysis plan. Analysis populations include full analysis, per-protocol, and safety sets. Diagnostic performance measures are calculated and compared between assessments with and without the investigational device. Interpretation time and inter-reader agreement are evaluated using appropriate statistical methods. Usability outcomes are summarized descriptively.

Data processing complies with applicable data protection regulations, including the EU General Data Protection Regulation 2016/679. The study is conducted in accordance with the Declaration of Helsinki and applicable regulatory and ethical requirements. Ethics committee approval is obtained prior to study initiation. As the study is observational and does not impact clinical decision-making, it is considered to pose minimal risk to participants.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Raquel Laza Bulls; Phone Number: +34 697 70 84 87; Email: raquel.laza@kenkoimalytics.com
• Study Contact Backup: Name: Eric Aguado Sarrió; Phone Number: +34 669 953 839; Email: eric@kenkoimalytics.com

Study Locations

• Spain
  • Alicante
    • Elche, Alicante, Spain, 03293
      • Hospital Universitario del Vinalopó
      • Contact: Hospital Universitario del Vinalopó; Phone Number: +34 966 67 98 00; Email: info@vinaloposalud.com
      • Principal Investigator: Julia Camps Herrero, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

1. 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:

   1. Staging,
   2. Assessment of response to neoadjuvant therapy,
   3. High suspicion of breast cancer, or
   4. Follow-up.
2. 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.
3. Women age 18 and older.
4. Adult women able to understand the informed consent and participant information sheet and provide voluntary consent for the study.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Five-point Likert confidence scale, ranging from 1 - Not confident at all to 5 -Extremely confident. Higher values indicate higher confidence in the MRI assessment with and without the study device.	Through MRI cases assessment during the study period (Months 1 to 11)
Inter-reader concordance	Inter-reader concordance for assessment with the study device	Before study initiation (5 training cases)
Usability of the study device assessed by System Usability Scale (SUS)	Usability of the study device assessed for each reader using the SUS, a standardized 10-item questionnaire with items that alternate between positively and negatively worded statements to reduce response bias. Each item is rated on a 5-point Likert scale, ranging from 1-Strongly disagree to 5-Strongly agree. Responses are converted to a standardized scoring format and summed, with the total score multiplied by 2.5 to yield a final SUS score ranging from 0 to 100. Scores above 85 indicate excellent usability, while scores between 68 and 84 indicate good usability. The questionnaire is completed once per reader, after the reader has completed all MRI image assessments with and without the study device.	At study completion, after each reader has completed all MRI image assessments with and without the study device (Month 11)
Usability of the study device assessed by task completion rate	Task completion rate assessed for each reader as the percentage of cases successfully processed with the study device without assistance or errors	At study completion, after each reader has completed all MRI image assessments with and without the study device (Month 11)
Usability of the study device assessed by error rate	Error rate assessed for each reader as the percentage of cases processed with the study device in which the user encountered errors	At study completion, after each reader has completed all MRI image assessments with and without the study device (Month 11)
Usability of the study device assessed by assistance rate	Assistance rate assessed for each reader as the percentage of cases processed with the study device in which the user requested assistance	At study completion, after each reader has completed all MRI image assessments with and without the study device (Month 11)
Usability of the study device assessed by time-on-task	Time-on-task assessed for each reader as the average time the user spent completing a case assessment with the study device	At study completion, after each reader has completed all MRI image assessments with and without the study device (Month 11)

Collaborators and Investigators

• Sponsor: Kenko Imalytics S.L.
• Collaborators: MDx CRO (MED IVD HEALTHTECH S.L.)

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Breast Cancer; Breast MRI; Breast Cancer Detection; Image Analysis; Medical Imaging Software
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: PROSKENKOBreastAI+

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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