3D Structural Imaging of Human Breast Tissues

Not yet recruiting

• Conditions: Human Breast Tissues
• Interventions: Device: Multi-photon microscopy

• Registration Number: NCT06454214
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

This project aims to develop an advanced ex vivo medical microscopic imaging technology. By developing breast tissue staining techniques, acquiring microscopic images, and performing structural reconstruction, we seek to observe the 3D structure of breast tissue. This includes examining cell distribution, mammary ducts, and blood vessel distribution, to explore the different biological characteristics between normal breast tissue and various types of cancerous tissues.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-06
• Study First Submitted QC: 2024-06-06
• Study First Posted: 2024-06-12
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-26
• Study Start: 2024-07-01
• Primary Completion: 2026-06-04
• Study Completion: 2027-06-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Adults aged 18 and above.
• Patients clinically diagnosed with breast cancer.

Exclusion Criteria

• Patients unable to provide consent (e.g., inability to speak, inability to communicate in Chinese, etc.).
• Patients for whom a definitive pathological diagnosis cannot be established.
• Patients suitable only for biopsy and not for surgical excision.
• Excised tissue showing severe radiation-induced changes under pathological examination.
• Tumor specimens smaller than 1 cm.
• Patients with ductal carcinoma in situ (DCIS).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cancerous breast tissues	Multi-photon microscopy	Tumor tissue contained within the surgically excised specimen
Control breast tissues (normal breast tissues)	Multi-photon microscopy	Normal tissue contained within the surgically excised specimen

Primary Outcome Measures

Name	Time	Method
Accuracy dependency on staining dye selection	3 years	Using other types of staining agents, compare the diagnostic accuracy of the results with those of traditional pathological staining agents.

Secondary Outcome Measures

Name	Time	Method
Comparison between 3D pathology vs. FFPE on breast cancer samples with a focus on image contrast	3 years	Verify whether the contrast and other conditions can provide pathologists with critical information for interpretation. The images will also be compared with the results observed using traditional pathology methods.