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Diagnostic Value of Sonazoid Contrast-enhanced Ultrasound in Renal Tumors

NCT ID: NCT04626115

Last Updated: 2020-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

223 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-08-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Contrast Enhanced Ultrasound

Keywords

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kidney

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ping Liang

Diagnostic performance of Sonazoid contrast-enhanced ultrasound in renal tumors

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ping Liang, doctor

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhigang Cheng, doctor

Role: CONTACT

Phone: 8601066939530

Email: [email protected]

Zhigang Cheng

Role: CONTACT

Email: [email protected]

Facility Contacts

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Ping Liang, Doctor

Role: primary

Other Identifiers

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S2020-300-2

Identifier Type: -

Identifier Source: org_study_id