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

NCT04825444 | Unknown

• 1 other identifier: KND-QX-CXXT
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Tumor; Ultrasonography

Keywords

photoacoustic imaging; Ultrasonography; Breast Tumor

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Photoacoustic inspection DEVICE

Use photoacoustic imaging system to image breast blood vessels

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast ultrasound results suggest that there is only a single mass on either side of the breast

You may qualify if:

• Female subjects aged ≥18 years old;
• 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;
• Able to comply with the research procedures specified in this program;
• Those who have fully understood the study before the experiment, volunteered to participate in the study and signed a written informed consent.

You may not qualify if:

• Those with incomplete skin (such as scratches, open wounds, ulcers, etc.) in the assessment side breast area;
• Those who have a history of surgery in the assessment side breast area;
• Those with persistent or active breast and/or axillary infection on the assessment side;
• Those who have a history of mental illness and cannot cooperate to complete the trial at present;
• Subjects deemed unsuitable by the investigator to participate in this study.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Union Photoacoustic technologies Co., Ltd: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yuxin Jiang, Doctor

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meng Yang, Doctor

CONTACT

8601060155494; yangmeng@pumch.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 1, 2021
• Study Start: March 31, 2021
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

CN (1)