Ultrasound-Guided Core Needle Biopsy to Assess Sensitivity and Specificity of Axillary Lymph Node Metastasis in Breast Cancer
1. maj 2026 opdateret af: Dezhi Zhang, The First Hospital of Jilin University
Sensitivity and Specificity of Ultrasound-Guided Core Needle Biopsy in Evaluating Axillary Lymph Node Metastasis in Breast Cancer
This study plans to find the most suitable lymph node cortex thickness and abnormal lymph node features to define suspicious lymph nodes.
Then, ultrasound-guided core needle biopsy of axillary lymph nodes will be done, aiming to provide some guidance for the biopsy.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Anslået)
200
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Dezhi Zhang
- Telefonnummer: 18186876068
- E-mail: dezhi@jlu.edu.cn
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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Consecutive patients newly diagnosed with primary breast cancer and assessed for axillary lymph node metastasis by ultrasound, prospectively enrolled from November 2025 to November 2026 across multiple hospitals.
Beskrivelse
Inclusion Criteria:
- Age ≥18 years and <70 years;
- Histologically confirmed primary breast cancer;
- Underwent ultrasound examination to assess axillary lymph node metastasis status.
Exclusion Criteria:
- Presence of other malignancies (e.g., lymphoma, lung cancer, thyroid cancer, etc., with axillary metastasis);
- Pregnant or lactating women;
- Previous receipt of neoadjuvant radiotherapy or chemotherapy;
- Lymph node metastasis status not confirmed by pathology, or time interval between ultrasound examination and pathological confirmation exceeding 6 weeks.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum cortical thickness of the lymph node (mm)
Tidsramme: Measurements should be performed prior to treatment initiation, with a time interval not exceeding 4 weeks between the measurement and pathological examination.
|
The maximum thickness of the lymph node's cortical layer.
Measured via conventional ultrasound examination of the lymph node's long-axis cross-section, perpendicular to the capsule surface, determining the maximum distance from the capsule to the corticomedullary junction.
|
Measurements should be performed prior to treatment initiation, with a time interval not exceeding 4 weeks between the measurement and pathological examination.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Age
Tidsramme: Baseline
|
Age of participants at the time of initial diagnosis of primary breast cancer, reported in years.
|
Baseline
|
|
Menstrual Status
Tidsramme: At initial diagnosis of primary breast cancer
|
Menstrual status at initial diagnosis of primary breast cancer, assessed by medical record review and categorized as premenopausal, perimenopausal, postmenopausal, or unknown.
|
At initial diagnosis of primary breast cancer
|
|
Lymph node axial ratio
Tidsramme: Measurements should be performed prior to treatment initiation, with a time interval not exceeding 4 weeks between the measurement and pathological examination.
|
The ratio of the maximum longitudinal diameter to the maximum transverse diameter of the lymph node.
The maximum longitudinal diameter and maximum transverse diameter of the lymph node are measured separately, and the axial ratio is obtained by dividing the measured longitudinal diameter value by the transverse diameter value.
|
Measurements should be performed prior to treatment initiation, with a time interval not exceeding 4 weeks between the measurement and pathological examination.
|
|
Lymph node margin regularity
Tidsramme: Measurements should be performed prior to treatment initiation, with a time interval not exceeding 4 weeks between the measurement and pathological examination.
|
Categorized as either regular or irregular.
|
Measurements should be performed prior to treatment initiation, with a time interval not exceeding 4 weeks between the measurement and pathological examination.
|
|
Lymph node hilum type
Tidsramme: Within 4 weeks before pathological examination and prior to treatment initiation
|
Lymph node hilum type assessed on pre-treatment imaging, categorized according to the presence or absence of the lymph node hilum.
|
Within 4 weeks before pathological examination and prior to treatment initiation
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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 (Anslået)
1. oktober 2026
Primær færdiggørelse (Anslået)
1. oktober 2027
Studieafslutning (Anslået)
1. oktober 2028
Datoer for studieregistrering
Først indsendt
24. april 2026
Først indsendt, der opfyldte QC-kriterier
1. maj 2026
Først opslået (Faktiske)
7. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 25K072-001
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