Actively Recruiting
Led by EXoPERT · Updated on 2026-01-08
330
Participants Needed
2
Research Sites
N/A
Total Duration
Researchers are evaluating a new in vitro diagnostic medical device developed by EXoPERT that uses a blood test to help classify patients at high or low risk for breast cancer. This trial focuses on detecting breast cancer earlier and more accurately by analyzing extracellular vesicles in the blood with a technology called Raman spectroscopy combined with artificial intelligence. The study aims to address limitations of current imaging methods like mammography and ultrasound, which can lead to unnecessary biopsies due to false-positive results. The investigational device, called ExoPred, measures Raman spectroscopic signals from extracellular vesicles extracted from human plasma. This device analyzes these signals using artificial intelligence to differentiate between high-risk and low-risk breast cancer patients. The study includes two groups: patients with malignant breast nodules and those with benign breast nodules. Participants will be adults female, aged 40 or older, whose lesions fall into BI-RADS categories 4, 5, or 6 and have undergone or are scheduled for biopsy. Participants will provide blood samples before any treatment or surgery, along with clinical and demographic information including breast density, tumor size, staging details, and medical history. Researchers will measure the device's sensitivity and specificity over an average of one year to assess its diagnostic performance. The trial will help determine how well this blood test can assist in breast cancer diagnosis and reduce unnecessary biopsies, with patient safety and clinical efficacy carefully monitored throughout the study period.
CONDITIONS
A Prospective Study to Develop and Clinically Validate an in Vitro Diagnostic Medical Device That Uses Blood to Classify Patients at High Risk for Breast Cancer
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks
Participants undergo blood sample collection for in vitro diagnostic testing using the ExoPred device to classify breast nodules as malignant or benign.
1 visit (in-person) for blood sample collection
Duration - Approximately 1 year
Participants are monitored for up to one year to evaluate the sensitivity and specificity of the diagnostic device through clinical follow-up.
Follow-up visits as per routine clinical care
Total: 2 locations
1
Korea University Anam Hospital
Seoul, South Korea
Actively Recruiting
2
Korea University Guro Hospital
Seoul, South Korea
Actively Recruiting
J
Jongwon Choi
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Sung Eun Song, Hyunku Shin, Yong Park...
https://pubmed.ncbi.nlm.nih.gov/41918185