Contrast Enhanced UltrasoundNCT04626115
Diagnostic Value of Sonazoid Contrast-enhanced Ultrasound in Renal Tumors
An observational study of Contrast Enhanced Ultrasound, run by Chinese PLA General Hospital at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Contrast Enhanced Ultrasound
- How many people
- 223 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- (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;。
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
Zhigang Cheng contact
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Ping Liang, Doctor
About this study
Official title: 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
Read the detailed 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.
- Conditions
- Contrast Enhanced Ultrasound
- Keywords
- kidney
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start1 Sep 2020
- Primary completionMar 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast Enhanced UltrasoundStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 223 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Liang, Chinese PLA General Hospital
- Investigators
- Ping Liang, doctor, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626115
- Sponsor's protocol ID
- S2020-300-2
- Status last verified
- Nov 2020
- First submitted
- 29 Sep 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Sonazoid Contrast-enhanced Ultrasound in Renal Tumors
- ClinicalTrials.gov ID
- NCT04626115
- Acronym / sponsor ID
- S2020-300-2
- Conditions
- Contrast Enhanced Ultrasound
- Keywords
- kidney
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 223 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- (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;。
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic performance of contrast-enhanced ultrasound in renal tumor by Sonazoid.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhigang Cheng contact
Ping Liang, doctor principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contrast Enhanced Ultrasound, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhigang Cheng, doctor (8601066939530, 13691367317@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of contrast-enhanced ultrasound in renal tumor by Sonazoid. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.