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

NCT ID: NCT06663228

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-17
• Study Completion Date: 2025-12-31

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

breast MMS

MMS

Intervention Type: DIAGNOSTIC_TEST

miniature mass spectrometry with AI assistance

Interventions

MMS

miniature mass spectrometry with AI assistance

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jo-Yu Chen

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Jo-Yu Chen, MD

Role: CONTACT

joyuchen@ntuh.gov.tw

+886223123456 ext. 262570

Facility Contacts

Jo-Yu Chen, MD

Role: primary

juoyu.chen@gmail.com

+886223123456 ext. 262570

Other Identifiers

202405152RINB

Identifier Type: -

Identifier Source: org_study_id