An observational study in Breast Cancer, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to female participants aged 20 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-10-29.
Sponsored by National Taiwan University Hospital · Observational
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 100 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Females with abnormal mammography findings, that were categoried as ACR BI-RADS 4 or 5, come for vacuum-assisted stereotactic breast biopsy.
Exclusion Criteria:
Diagnostic Test: MMS
miniature mass spectrometry with AI assistance
breast cancer
PATHOLOGICAL DIAGNOSIS To prove the biopsy specimen to be malignant or benign.
Time frame: July 2024 to July 2025
Plan to share: No
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National Taiwan University Hospital