- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03708978
Development of Artificial Intelligence System for Detection and Diagnosis of Breast Lesion Using Mammography
24. juli 2021 opdateret af: Sun Ying-Shi, Peking University Cancer Hospital & Institute
This project aims to establish a comprehensive artificial intelligence system for detecting and qualitative diagnosing breast lesions.
Mammary images will be used to construct a diagnosis method based on deep learning.
The system is proposed to automatically analyze the type of mammary glands, automatically identify and mark all breast lesions on the mammography images, provide the malignancy probability judgment of the lesions, the BI-RADS classification and the clinical suggestion, and also automatically generate the structured diagnosis report.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a multi-center study.The project contains a retrospective part(3000 samples anticipated) and a prospective part(7000 samples anticipated).
In the retrospective part, investigators collected subjects with mammary images to design the deep learning method and construct a detective and diagnostic model for breast lesions.
In the prospective part, investigators validate the accuracy of the constructed deep learning method, and established artificial intelligence system focusing on mammary diagnosis.
Investigators will also explore the application pattern of the artificial intelligence system in clinical practice.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
5809
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Beijing
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Beijing, Beijing, Kina, 100142
- Beijing Cancer Hospital
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Beijing, Beijing, Kina
- Beijing Chao Yang Women and Children's Health Hospital
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Beijing, Beijing, Kina
- Beijing Da Xing People's Hospital
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Beijing, Beijing, Kina
- Beijing Hang Tian Centre Hospital
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Beijing, Beijing, Kina
- Beijing Nan Jiao Cancer Hospital
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Beijing, Beijing, Kina
- Beijing Shi Jing Shan Hospital
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Beijing, Beijing, Kina
- Beijing Shun Yi Qu Hospital
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Beijing, Beijing, Kina
- Beijing Shun Yi Woman and Children Health Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Women with suspected Breast Lesion
Beskrivelse
Inclusion Criteria:
- the X-ray images of the breast were complete
- the results of pathological diagnosis or more than 2 years of mammography follow-up were available
- subject signs informed consent(this item was only for prospective study cases)
Exclusion Criteria:
- there exists pathological diagnosis of breast lesions when receiving mammography
- there lacks pathological diagnosis or 2 years of mammography follow-up
- subject withdraws(this item was only for prospective study cases)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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mammography group
women who receives mammography because of suspected breast lesion(s)
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When a woman comes to the clinic to receive mammography.
Then a radiologist will give a BI-RADS classification after reviewing the images.
If a BI-RADS 4/5 is obtained, the woman will receive pathological biopsy to ensure there is a benign or malignant lesion.
If a BI-RADS 3 is obtained, the woman will be followed up by a half-year interval until two year after the first mammography.
At each follow up, she will receive mammography.
If a BI-RADS 4/5 is obtained at follow up, she will receive pathological biopsy; if a BI-RADS 1/2/3 is obtained at follow up, she will be followed up by a half-year interval until two year.
If a BI-RADS 1/2 is obtained at the first mammography, the woman will receive a second mammography after two year.
During the study period, breast examination and results will be recorded for every subject.
Radiologists will give the diagnosis with and without AI support.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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benign-malignant diagnosis accuracy
Tidsramme: from the first mammography to pathological result obtained(an average of 3 weeks if mammography BI-RADS 4 or 5 obtained)
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the accuracy of the AI model, radiogist with AI support, radiologist alone for binary diagnosis of a benign or malignant breast lesion according to pathology.
If either one mammography of BI-RADS 4/5 in the first examination or during the two year' follow up examination is obtained,a pathological examination is performed, the lesion is judged benign or malignant according to pathological results.
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from the first mammography to pathological result obtained(an average of 3 weeks if mammography BI-RADS 4 or 5 obtained)
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benign-malignant diagnosis accuracy
Tidsramme: from the first mammography to 2-year-after mammography
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the accuracy of the AI model, radiogist with AI support, radiologist alone for binary diagnosis of a benign or malignant breast lesion according to follow up.
If a 2-year mammography of BI-RADS 1/2/3 is obtained, the lesion is considered benign.
If either one mammography of BI-RADS 4/5 during the two year is obtained,a pathological examination is performed to ensure the benign or malignant lesion
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from the first mammography to 2-year-after mammography
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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lesion detection accuracy
Tidsramme: from the first mammography to radiologist diagnosis (within 3 days after the mammography taken)
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the detection rate of the constructed deep learning method for detecting benign or malignant breast lesion according to radiologist's subjective diagnosis or follow up as reference.
If a radiologist suggests existence of a lesion at the first mammography or at each follow-up mammography during the 2-year period, it is considered that a lesion exists
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from the first mammography to radiologist diagnosis (within 3 days after the mammography taken)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Studiestol: Ying-Shi Sun, Professor, Peking University Cancer Hospital & Institute
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
5. april 2018
Primær færdiggørelse (Faktiske)
4. maj 2020
Studieafslutning (Faktiske)
4. maj 2020
Datoer for studieregistrering
Først indsendt
17. april 2018
Først indsendt, der opfyldte QC-kriterier
12. oktober 2018
Først opslået (Faktiske)
17. oktober 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. juli 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. juli 2021
Sidst verificeret
1. juli 2021
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- BCA-AI
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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Kliniske forsøg med mammography
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American College of RadiologyGE Healthcare; Breast Cancer Research FoundationRekrutteringBrystkræftForenede Stater
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Memorial Sloan Kettering Cancer CenterGE HealthcareAfsluttetBrystkræftForenede Stater
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University of Southern CaliforniaNational Cancer Institute (NCI)AfsluttetBrystkarcinomForenede Stater
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Levine, Gary M. , M.D.Hologic, Inc.UkendtEn evaluering af et selvstændigt direkte digitalt radiografisystem til billeddannelse af brystprøverBrystkræftForenede Stater
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Memorial Sloan Kettering Cancer CenterAfsluttet