Diagnostic Value of Sonazoid Contrast-enhanced Ultrasound in Renal Tumors
10. november 2020 opdateret af: Ping Liang, Chinese PLA General Hospital
Diagnostic Performance of Sonazoid Contrast-enhanced Ultrasound in Renal Tumors
The incidence and mortality of renal cell carcinoma are increasing year by year.
Contrast-enhanced ultrasound is helpful for early diagnosis and treatment to renal tumor, and is of great importance to distinguish benign from malignant and clinical stages
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
The morbidity of renal cell carcinoma is only lower to prostate cancer and bladder cancer in urinary tumor, and the mortality rate is up to 40%.
At present, diagnostic techniques such as ultrasonography, CT examination and MRI examination are widely used in Clinical practice, which greatly improves the detection rate of asymptomatic renal cell carcinoma.
Compared with enhanced MRI and enhanced CT, contrast-enhanced ultrasound (CEUS) has outstanding advantages, including spatial, temporal and contrast resolution, continuous real-time visualization,.
Sonazoid, the second generation ultrasound contrast agent, is composed of microbubbles containing chemically stable and insoluble perfluorobutane (PFB) gas and phosphatidylserine sodium hard shell (diameter 2-3μm) wrapped by outer layer.
These microbubbles can generate stable nonlinear oscillation in low-power sound field, and generate echo at the second harmonic frequency of transmitted pulse.
Sonazoid has the advantages of long-time development and good stability, which may improve the accuracy of distinguishing benign and malignant renal space-occupying lesions, especially small lesions.
In addition, the characteristics of long-time development are also helpful to extract more imaging information to assist the clinical staging of renal tumors.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
223
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Beijing
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Beijing, Beijing, Kina, 100853
- Rekruttering
- Chinese PLA General 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 til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
N/A
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
The requirements of the case report form, the age, sex, smoking history, hypertension, diabetes, coronary heart disease, stroke history, general condition of the patients and physical examination results of the patients should be registered for outpatient or inpatient patients after obtaining the informed consent of the patients.
If the patient is undergoing surgical treatment, record the operation mode, results and complications of the patient. Patients who need comprehensive treatment after operation should record the treatment measures and the name, usage and dosage of drugs.
Contact information (fixed telephone or mobile phone) of at least two patients and their families should be obtained for future follow-up.
Beskrivelse
Inclusion Criteria:
- (1) The subjects are able and willing to abide by the research procedure and sign the informed consent form; (2) The subjects who received CECT or CEMRI examination of renal tumor before the treatment; (4) Patients with no serious cardiovascular and cerebrovascular diseases; (5) Patients who intend to undergo biopsy or lesion resection；(6) aged 18 -85;。
Exclusion Criteria:
- (1) pregnant or lactating patients; (2) The subject has a history of allergy to eggs or egg products (i.e., general rash, dyspnea, swelling of mouth or throat, hypotension or shock, etc.); (3) It is known that the subject is allergic to perfluorobutane gas or any component of Sonazoid; (4) Patients who can't receive contrast MRI or enhanced CT examination.
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 |
|---|---|---|
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Diagnostic performance of contrast-enhanced ultrasound in renal tumor by Sonazoid.
Tidsramme: 1 year
|
Pathology as a gold standard, to compare the diagnostic performance between contrast-enhanced ultrasound and other contrast-enhanced imaging in renal tumor by Sonazoid.
|
1 year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
1. september 2020
Primær færdiggørelse (Forventet)
1. marts 2021
Studieafslutning (Forventet)
1. august 2021
Datoer for studieregistrering
Først indsendt
29. september 2020
Først indsendt, der opfyldte QC-kriterier
10. november 2020
Først opslået (Faktiske)
12. november 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. november 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. november 2020
Sidst verificeret
1. november 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- S2020-300-2
Plan for individuelle deltagerdata (IPD)
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INGEN
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