3D Structural Imaging of Human Breast Tissues

June 24, 2024 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This research project aims to recruit 100 subjects and acquire three-dimensional images of the breast tissues. After reconstructing these images, the study will explore the diverse three-dimensional structures of tumor tissues and compare them with the structures of normal breast tissues.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control breast tissues (normal breast tissues)
Normal tissue contained within the surgically excised specimen
Device: Multi-photon microscopy
To conduct 3D structural imaging on human breast tissues
Cancerous breast tissues
Tumor tissue contained within the surgically excised specimen
Device: Multi-photon microscopy
To conduct 3D structural imaging on human breast tissues

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

June 4, 2026

Study Completion (Estimated)

June 4, 2027

Study Registration Dates

First Submitted

June 6, 2024

First Submitted That Met QC Criteria

June 6, 2024

First Posted (Actual)

June 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 26, 2024

Last Update Submitted That Met QC Criteria

June 24, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202405097RINB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This study will not share individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Human Breast Tissues

Clinical Trials on Multi-photon microscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe