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Not yet recruiting NCT06454214

3D Structural Imaging of Human Breast Tissues

Observational Human Breast Tissues

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multi-photon microscopy.
Who it may be relevant to
Registry conditions: Human Breast Tissues. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Device Multi-photon microscopy
    To conduct 3D structural imaging on human breast tissues

Primary outcome measures

  • Accuracy dependency on staining dye selection [Time frame: 3 years]
Secondary outcome measures (1)
  • Comparison between 3D pathology vs. FFPE on breast cancer samples with a focus on image contrast [Time frame: 3 years]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06454214 · 202405097RINB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗