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临床试验/NCT06663228
NCT06663228招募中不适用

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

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年7月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
breast cancer

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Those who come for receiving vacuum-assisted stereotactic breast biopsy

排除标准

  • Those who cannot or are unwilling to sign the informed consent.

结局指标

主要结局

breast cancer

时间窗: July 2024 to July 2025

PATHOLOGICAL DIAGNOSIS To prove the biopsy specimen to be malignant or benign.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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