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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06663228
Enrollment
100
Registered
2024-10-29
Start date
2024-07-17
Completion date
2025-12-31
Last updated
2024-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, breast biopsy, miniature mass spectrometry, artificial intelligence

Brief 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.

Interventions

DIAGNOSTIC_TESTMMS

miniature mass spectrometry with AI assistance

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
breast cancerJuly 2024 to July 2025PATHOLOGICAL DIAGNOSIS To prove the biopsy specimen to be malignant or benign.

Countries

Taiwan

Contacts

Primary ContactJo-Yu Chen, MD
joyuchen@ntuh.gov.tw+886223123456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026