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

NCT06663228 | Recruiting

• 1 other identifier: 202405152RINB
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• breast cancer

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

  July 2024 to July 2025

Study Arms (1)

breast MMS

Diagnostic Test: MMS

Interventions

MMS DIAGNOSTIC_TEST

miniature mass spectrometry with AI assistance

breast MMS

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Females with abnormal mammography findings, that were categoried as ACR BI-RADS 4 or 5, come for vacuum-assisted stereotactic breast biopsy.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Jo-Yu Chen

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jo-Yu Chen, MD

CONTACT

+886223123456; joyuchen@ntuh.gov.tw

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: October 29, 2024
• Study Start: July 17, 2024
• Primary Completion: July 4, 2025
• Study Completion: December 31, 2025
• Last Updated: October 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)