NCT04825444

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 152 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Tumor
• Ultrasonography

Interventions

Type	Name	Description
DEVICE	Photoacoustic inspection	Use photoacoustic imaging system to image breast blood vessels

Timeline

• Start date: 2021-03-31
• Primary completion: 2021-10-31
• Completion: 2021-12-31
• First posted: 2021-04-01
• Last updated: 2021-04-01

Locations

1 site across 1 country: China