Clinical Study of Vascular Imaging Evaluation of Computed Tomography Photoacoustic Breast Imaging System

Ultrasonography Clinical Trial

Official title:

Clinical Study of Vascular Imaging Evaluation of Computed Tomography Photoacoustic Breast Imaging System

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04825444
• Other study ID #: KND-QX-CXXT
• Status: Not yet recruiting
• Start date: March 31, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: Peking Union Medical College Hospital
• Contact: Meng Yang, Doctor
• Phone: 8601060155494
• Email: yangmeng[@]pumch.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Using color Doppler ultrasound to screen people with breast masses. For the patients who show only a single mass on either side of the breast in color Doppler ultrasound, computer tomography photoacoustic breast imaging will be performed. By comparing the two modalities, the blood vessel imaging performance of the computer tomography photoacoustic breast imaging system developed by Union Photoacoustic technologies Co., Ltd is evaluated.

The evaluation index of this experiment is the percentage of blood vessel pixels in the same region of interest (Region Of Interest, ROI) to the total area of the ROI.

Description:

Screening of people with breast tumors, through breast color Doppler ultrasound examination, the results showed that there is only a single tumor on either side of the breast. The computer tomography photoacoustic breast imaging system was used to perform breast examination again. By comparing ultrasound and photoacoustic vascular imaging, the vascular imaging of the computer tomography photoacoustic breast imaging system developed by Union Photoacoustic technologies Co., Ltd was evaluated.

This test does not evaluate the diagnosis or treatment performance of two imaging modalities. It only compares the vascular imaging of two different imaging systems. Therefore, the evaluation index of this experiment is the percentage of blood vessel pixel number in the same region of interest (ROI) to the total pixel number in ROI. By comparing the percentages of blood vessel pixel number to the total pixel number in the same ROI in ultrasound and computerized tomography photoacoustic breast imaging system, the vascular imaging of the computerized tomography photoacoustic breast imaging system is evaluated.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 152
• Est. completion date: December 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Female subjects aged =18 years old;

2. Those who have undergone breast color Doppler ultrasound examination in this hospital, and the results show that there is only a single tumor on either side of the breast;

3. Able to comply with the research procedures specified in this program;

4. Those who have fully understood the study before the experiment, volunteered to participate in the study and signed a written informed consent.

Exclusion Criteria:

1. Those with incomplete skin (such as scratches, open wounds, ulcers, etc.) in the assessment side breast area;

2. Those who have a history of surgery in the assessment side breast area;

3. Those with persistent or active breast and/or axillary infection on the assessment side;

4. Those who have a history of mental illness and cannot cooperate to complete the trial at present;

5. Subjects deemed unsuitable by the investigator to participate in this study.

Related Conditions & MeSH terms

• Breast Neoplasms
• Breast Tumor
• Ultrasonography

Intervention

Device:
• Photoacoustic inspection
Use photoacoustic imaging system to image breast blood vessels

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Union Photoacoustic technologies Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ROI percentage	The evaluation index of this experiment is the percentage of blood vessel pixel number in the same region of interest (ROI) to the total pixel number in ROI	Immediately After photoacoustic inspection