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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 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-05-12

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • MDx CRO (MED IVD HEALTHTECH S.L.)

    collaborator UNKNOWN

  • Kenko Imalytics S.L.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07580105 on ClinicalTrials.gov