RecruitingNCT06663228

Rapid Histologic Assessment for Stereotactic Breast Biopsy: Enhancing Early Detection With Miniature Mass Spectrometry and AI


Sponsor

National Taiwan University Hospital

Enrollment

100 participants

Start Date

Jul 17, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

Breast cancer is the leading cancer among Taiwanese women, and it is the second leading cause of cancer-related deaths in women. The five-year survival rate for early-stage breast cancer (Stage 0 to II) is over 90%, significantly better than the survival rates for Stage III and Stage IV breast cancer, which are approximately 70% and 25%, respectively. As a result, breast cancer screening and early diagnosis have always been of great importance. Breast cancer screening relies on imaging examinations, and the diagnosis depends on imaging-guided tissue confirmation. However, when a patient undergoes stereotactic breast biopsy due to suspicious lesions found in mammography, they typically have to wait about a week to receive the pathology results to determine whether the lesion is benign or malignant. For the patient, this waiting period can be agonizing, and for clinicians, earlier knowledge of pathology results would facilitate prompt staging evaluation and treatment planning for cancer. The investigators use a special technique-paper spray ionization miniature mass spectrometry (PSI-MMS). According to preliminary research, with the assistance of AI, the miniature mass spectrometer can detect the benign or malignant nature of breast tissue within minutes and with decent accuracy. The investigators hope to continue research to further improve accuracy to meet clinical needs and aspire to have the opportunity to apply the miniature mass spectrometer to rapidly differentiate the molecular subtypes of breast cancer.


Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new miniature mass spectrometry device that, combined with artificial intelligence, can rapidly analyze breast tissue samples taken during a stereotactic vacuum-assisted biopsy (a common procedure to assess suspicious breast lumps or abnormalities on mammograms). The goal is to improve the speed and accuracy of early breast cancer detection. **You may be eligible if...** - You are scheduled to have a vacuum-assisted stereotactic breast biopsy **You may NOT be eligible if...** - You are unable or unwilling to sign the informed consent form Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTMMS

miniature mass spectrometry with AI assistance


Locations(1)

Jo-Yu Chen

Taipei, Taiwan

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NCT06663228


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