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NCT Number: NCT06454214

3D Structural Imaging of Human Breast Tissues

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.

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Key information

Conditions

Human Breast Tissues Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Multi-photon microscopy

Device

To conduct 3D structural imaging on human breast tissues

Primary outcomes

  1. Accuracy dependency on staining dye selection

    Time frame: 3 years

    Using other types of staining agents, compare the diagnostic accuracy of the results with those of traditional pathological staining agents.

Secondary outcomes

  1. Comparison between 3D pathology vs. FFPE on breast cancer samples with a focus on image contrast

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ming-Yang Wang, PhD

CONTACT

[email protected]

+886-23123456 ext. 263155

Yao-Chen Tseng, Master

CONTACT

[email protected]

+886-33661552

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 12, 2024
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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