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Comparison of Ultrasound Contrast Agent Sonovue and Sonazoid in the Application of Colorectal Liver Metastasis: a Prospective Single Center Study

Comparison of Ultrasound Contrast Agent Sonovue and Sonazoid in the Application of Colorectal Liver Metastasis: a Prospective Single Center Study

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000038055
Enrollment
Unknown
Registered
2020-09-09
Start date
2020-09-01
Completion date
Unknown
Last updated
2021-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal liver metastasis

Interventions

Sonazoid&#32
agent.
ultrasound&#32
based&#32
on&#32
Gold Standard:Pathological diagnosis of surgically resected lesions and intraoperative ultrasound diagnosis of non-surgically resected lesions

Sponsors

Peking University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Clinical and MRI examinations clearly diagnosed colorectal liver metastasis; (2) The number of lesions in the liver = 3.0 x 10^9/L; The absolute value of neutrophils >= 1.5 x 10^9/L; Platelet count >= 100 x 10^9/L; Hemoglobin >= 90 g/L; Serum albumin >= 2.5 g/dL; Liver function: total bilirubin = 50 mL/min (Cockcroft and Gault formula); International normalized ratio (INR) <= 1.5, and activated partial thromboplastin time (APTT) or partial prothrombin time (PTT) <= 1.5 x ULN.

Exclusion criteria

Exclusion criteria: (1) Unable to operate with relevant contraindications for surgery; (2) The patient's compliance is poor, and the disease is expected to be unable to obtain a clear diagnosis; (3) The patient is accompanied by any unstable systemic diseases, including but not limited to: severe infection, uncontrolled diabetes, unstable angina, cerebrovascular accident or transient cerebral ischemia, myocardial infarction, congestive heart failure, Severe arrhythmia, liver, kidney or metabolic diseases that require medication; (4) The patient's accompanying diseases (such as mental illness, etc.) or conditions (such as alcohol or drug abuse, etc.) will increase the patient's risk of receiving ultrasound examinations or affect the patient's compliance with research requirements, or may confuse the research results; (5) Patients who are known to be allergic to ultrasound contrast agents (Senovi or Shizhuoan) or its active ingredients and excipients; (6) Women who are pregnant or breastfeeding or who intend to become pregnant or breastfeeding during the study period; (7) There are contraindications mentioned in the instructions for MRI or ultrasound contrast agents.

Design outcomes

Primary

MeasureTime frame
SEN, SPE, ACC, AUC of ROC, PPV, NPV;The location and size of the lesion;the location and size of the lesion;Pathological diagnosis and specimen size measurement;

Countries

China

Contacts

Public ContactKun Yan

Peking University Cancer Hospital

ydbz@vip.sina.com+86 13611176073

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026