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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04825444
Enrollment
152
Registered
2021-04-01
Start date
2021-03-31
Completion date
2021-12-31
Last updated
2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Tumor, Ultrasonography

Keywords

photoacoustic imaging, Ultrasonography, Breast Tumor

Brief 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.

Interventions

DEVICEPhotoacoustic inspection

Use photoacoustic imaging system to image breast blood vessels

Sponsors

Union Photoacoustic technologies Co., Ltd
CollaboratorUNKNOWN
Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
ROI percentageImmediately After photoacoustic inspectionThe 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

Countries

China

Contacts

Primary ContactMeng Yang, Doctor
yangmeng@pumch.cn8601060155494

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026