Diagnostic Value of Sonazoid Contrast-enhanced Ultrasound in Renal Tumors

NCT04626115 | Unknown

• 1 other identifier: S2020-300-2
• Study Type: observational
• Target: 223
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Contrast Enhanced Ultrasound

Keywords

kidney

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• (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;。

You may not qualify if:

• (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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Study Officials

• Ping Liang, doctor

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhigang Cheng, doctor

CONTACT

8601066939530; 13691367317@163.com

Zhigang Cheng

CONTACT

13691367317@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Diagnostic performance of Sonazoid contrast-enhanced ultrasound in renal tumors

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: November 12, 2020
• Study Start: September 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: August 1, 2021
• Last Updated: November 12, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)