Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

30. mars 2021 oppdatert av: Peking Union Medical College Hospital

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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Enhet: Photoacoustic inspection

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

152

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Kina
- - Beijing, Kina
    - Peking Union Medical College Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
ROI percentage Tidsramme: 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	Immediately After photoacoustic inspection

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Peking Union Medical College Hospital

Samarbeidspartnere

Union Photoacoustic technologies Co., Ltd

Etterforskere

Hovedetterforsker: Yuxin Jiang, Doctor, Peking Union Medical College Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

31. mars 2021

Primær fullføring (Forventet)

31. oktober 2021

Studiet fullført (Forventet)

31. desember 2021

Datoer for studieregistrering

Først innsendt

28. mars 2021

Først innsendt som oppfylte QC-kriteriene

30. mars 2021

Først lagt ut (Faktiske)

1. april 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)