Human Breast TissuesNCT06454214
3D Structural Imaging of Human Breast Tissues
An observational study of Human Breast Tissues, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Breast Tissues
- What is being tested?
- Multi-photon microscopy
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 4 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults aged 18 and above.
- Patients clinically diagnosed with breast cancer.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Human Breast Tissues
- Being tested
- Multi-photon microscopy
- Keywords
- breast tumor, tumor assessment, tumor microenvironment, digital pathology, 3D pathology
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-photon microscopyDevice
To conduct 3D structural imaging on human breast tissues
| Study group | Role | What they receive |
|---|---|---|
| Control breast tissues (normal breast tissues) | Normal tissue contained within the surgically excised specimen Receives: Device: Multi-photon microscopy | |
| Cancerous breast tissues | Tumor tissue contained within the surgically excised specimen Receives: Device: Multi-photon microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy dependency on staining dye selection
Using other types of staining agents, compare the diagnostic accuracy of the results with those of traditional pathological staining agents.
Measured: 3 years
Secondary outcomes (1)
Comparison between 3D pathology vs. FFPE on breast cancer samples with a focus on image contrast
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion4 Jun 2026 (estimated)
- Study completion4 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Breast TissuesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454214
- Sponsor's protocol ID
- 202405097RINB
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study will not share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Structural Imaging of Human Breast Tissues
- ClinicalTrials.gov ID
- NCT06454214
- Acronym / sponsor ID
- 202405097RINB
- Conditions
- Human Breast Tissues
- Keywords
- breast tumor, tumor assessment, tumor microenvironment, digital pathology, 3D pathology
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 4 Jun 2026 (estimated)
- Study completion
- 4 Jun 2027 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control breast tissues (normal breast tissues) | – | Device: Multi-photon microscopyNormal tissue contained within the surgically excised specimen |
| Cancerous breast tissues | – | Device: Multi-photon microscopyTumor tissue contained within the surgically excised specimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adults aged 18 and above.
- Patients clinically diagnosed with breast cancer.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-photon microscopyTo conduct 3D structural imaging on human breast tissues | Device | Cancerous breast tissues, Control breast tissues (normal breast tissues) |
Primary outcome
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.
1 secondary outcome
Comparison between 3D pathology vs. FFPE on breast cancer samples with a focus on image contrast
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: No. This study will not share individual participant data.
Related trials for Human Breast Tissues
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
RecruitingPhase 3
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
PIK3CA Mutation, HER2- Negative Breast Cancer
Not yet recruiting
Prospective Study to Evaluate the Clinical Utility of ctDNA Tumor Fraction (TF) for Detection of Estrogen Receptor 1 (ESR1) Mutations in (Human Epidermal Growth Factor Receptor) HR+/HER2- Metastatic Breast Cancer (MBC)
Breast Cancer, Metastatic Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Breast Tissues, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming-Yang Wang, PhD (+886-23123456 ext. 263155, A00581@ntucc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy dependency on staining dye selection (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.