Clinical trial NCT04825444: Clinical Study of Vascular Imaging Evaluation of Computed Tomography Photoacoustic Breast Imaging System
Official title: Clinical Study of Vascular Imaging Evaluation of Computed Tomography Photoacoustic Breast Imaging System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Tumor
Ultrasonography
Keywords: photoacoustic imaging
Ultrasonography
Breast Tumor
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Union Photoacoustic technologies Co., Ltd
First posted: 2021-04-01
Enrollment: 152
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast ultrasound results suggest that there is only a single mass on either side of the breast

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.

Eligibility criteria: 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.

Primary outcomes:
measure: ROI percentage
timeFrame: Immediately After photoacoustic inspection
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yuxin Jiang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: