Diagnostic Value of Sonazoid Contrast-enhanced Ultrasound in Renal Tumors

Contrast Enhanced Ultrasound Clinical Trial

Official title:

Diagnostic Performance of Sonazoid Contrast-enhanced Ultrasound in Renal Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04626115
• Other study ID #: S2020-300-2
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: August 2021

Study information

• Verified date: November 2020
• Source: Chinese PLA General Hospital
• Contact: Zhigang Cheng, doctor
• Phone: 8601066939530
• Email: 13691367317[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 223
• Est. completion date: August 2021
• Est. primary completion date: March 2021
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contrast Enhanced Ultrasound
• Kidney Neoplasms

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic performance of contrast-enhanced ultrasound in renal tumor by Sonazoid.	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