Microscopy Imaging of Whole-mount Stained Human Tissues

Tumor, Brain Clinical Trial

Official title:

Microscopy Imaging of Whole-mount Stained Human Tissues: Development of an Imaging Platform for Intraoperative Tumor Margin Delineation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05689112
• Other study ID #: 202211038RINA
• Status: Recruiting
• Start date: January 10, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2023
• Source: National Taiwan University Hospital
• Contact: Yi-Hua YH Liao, PhD
• Phone: +886-23123456
• Email: yihualiao[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The goal of this clinical trial is to develop an imaging platform for intraoperative tumor margin delineation in 250 cases of tumor-suffered patients. The main questions it aims to answer are:

• to develop the protocol of rapid assessment of surgical specimens without need for fixation, embedding, and cryosectioning required for conventional histopathology.

Participants will provide a small piece of their surgical specimens from tumor removal surgery .

If there is a comparison group: Researchers will compare normal specimens to see if we can observe the difference.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Patients who are more than 20 years old.

2. Diagnosed as patients suffered by skin tumor, brain tumor and breast tumor.

Exclusion Criteria:

1. Patients who can't speak and communicate with others.

2. Patients who can't make eventual and exact pathological assessment for his/her diseases.

3. Patients who only can fit for slicing tumor.

4. Removed tissues which obviously vary after severe ray radiation under microscopy observation.

5. Diameter of tumors are under 1 centimeter.

6. Breast carcinoma in situ.

Related Conditions & MeSH terms

• Brain Neoplasms
• Breast Neoplasms
• Neoplasms
• Tumor Skin
• Tumor, Brain

Locations

Country	Name	City	State
Taiwan	Department of Dermatology, National Taiwan University Hospital and College of Medicine, National Taiwan University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The assessment between tumor cases and control cases	Do comparison with images acquired by our microscopy (with the whole-mount staining method) and bright field microscopy (with standard FFPE method) and do assessment to interpret tumor characteristics	5 years