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

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04825444
Collaborator
Union Photoacoustic technologies Co., Ltd (Other)
152
1
9
16.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Photoacoustic inspection

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
152 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Clinical Study of Vascular Imaging Evaluation of Computed Tomography Photoacoustic Breast Imaging System
Anticipated Study Start Date :
Mar 31, 2021
Anticipated Primary Completion Date :
Oct 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Outcome Measures

Primary Outcome Measures

  1. ROI percentage [Immediately After photoacoustic inspection]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking Union Medical College Hospital Beijing China

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Yuxin Jiang, Doctor, Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT04825444
Other Study ID Numbers:
  • KND-QX-CXXT
First Posted:
Apr 1, 2021
Last Update Posted:
Apr 1, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Peking Union Medical College Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 1, 2021