Bladder CancerUCEADP-BCSNCT06775977
Ultrasound Contrast-Enhanced Accurate Diagnosis of Preoperative Staging of Bladder Cancer
An observational study of Bladder Cancer and Staging, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Ultrasound and magnetic resonance imaging (MRI) technologies have become essential tools for the diagnosis and preoperative staging assessment of bladder cancer. However, establishing a precise system suitable for clinical application remains a significant challenge, and accurate prediction of bladder cancer staging… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bladder Cancer, Staging, Contrast Enhanced Ultrasound
- What is being tested?
- Contrast Enhanced Ultrasound (CEUS)
- Type of treatment
- Injection or infusion
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who have a histologically or cytologically confirmed diagnosis of primary bladder cancer
Who may be able to join
- (a) eligible patients should be 18-year-old or older;
- (b) patients should have a histologically or cytologically confirmed diagnosis of primary bladder cancer;
- (c) patients should not have had any surgery, chemotherapy, immunotherapy, or any therapy before CEUS diagnosis.
Who cannot join
- (a) participants with confirmed to have no carcinoma of the bladder;
- (b) participants with previous pelvic surgery, who had undergone therapy, any bladder surgery, or had received chemotherapy, radiotherapy or immunotherapy;
- (c) participants diagnosed with tumor recurrence or metastasis; (d) participants who were allergic to ultrasound contrast agents or could not tolerate CEUS examination, for instance, with recent myocardial infarction, angina pectoris, cardiac insufficiency, severe cardiac arrhythmia, a right/left cardiac shunt, severe pulmonary hypertension, uncontrolled systemic hypertension, acute respiratory distress syndrome, or chronic obstructive pulmonary disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Ou, Dr., 020-34071020, ouqy5@mail.sysu.edu.cn
About this study
Official title: Ultrasound Contrast-Enhanced Accurate Diagnosis of Preoperative Staging of Bladder Cancer: a Prospective, Observational Study
Ultrasound and magnetic resonance imaging (MRI) technologies have become essential tools for the diagnosis and preoperative staging assessment of bladder cancer. However, establishing a precise system suitable for clinical application remains a significant challenge, and accurate prediction of bladder cancer staging is not yet possible. Therefore, exploring a system for the precise diagnosis of preoperative staging of bladder cancer using ultrasound contrast enhancement or a combination of ultrasound contrast enhancement and MRI is of great importance. The applicant has previously demonstrated the accuracy of multimodal data analysis in the diagnosis and prediction of malignant tumors. Preliminary results from this study have shown that ultrasound contrast enhancement has a high diagnostic efficacy for the preoperative staging assessment of bladder cancer, with a high area under the curve (AUC) of 0.88, sensitivity of 83.3%, specificity of 92.5%, and accuracy of 90.8%. In this project, the applicant intends to further expand the sample size and, based on the combination of ultrasound contrast enhancement and MRI, develop a precise diagnostic system for the preoperative staging of bladder cancer to aid clinical treatment decisions.
- Conditions
- Bladder Cancer, Staging, Contrast Enhanced Ultrasound
- Being tested
- Contrast Enhanced Ultrasound (CEUS)
- Keywords
- Bladder Cancer, Contrast-Enhanced Ultrasonography
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast Enhanced Ultrasound (CEUS)Diagnostic test
Contrast Enhanced Ultrasound (CEUS) refers to the observation under ultrasound after the injection of ultrasound contrast agents, such as SonoVue or Lumason.
| Study group | Role | What they receive |
|---|---|---|
| Contrast-enhanced Ultrasonography | To evaluate the diagnostic accuracy of CEUS for the preoperative staging of bladder cancer, which would benefit the implementation of efficient therapeutic strategies. Receives: Diagnostic Test: Contrast Enhanced Ultrasound (CEUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Muscle Invasion in Bladder Cancer
To evaluate the preoperative staging of bladder cancer，whether it is non-muscle invasive bladder cancer (NMIBC) or muscle invasive bladder cancers (MIBC)
Measured: within 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 480 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiyun Ou, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Luo, Prof., Study director, Department of Ultrasound in Medicine, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775977
- Sponsor's protocol ID
- SYSKY-2024-145-01
- Other IDs
- Grant No.2023CSM003
- Acronym
- UCEADP-BCS
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Contrast-Enhanced Accurate Diagnosis of Preoperative Staging of Bladder Cancer: a Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT06775977
- Acronym / sponsor ID
- UCEADP-BCS / SYSKY-2024-145-01
- Conditions
- Bladder Cancer, Staging, Contrast Enhanced Ultrasound
- Keywords
- Bladder Cancer, Contrast-Enhanced Ultrasonography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Jan 2025 (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.
Ultrasound and magnetic resonance imaging (MRI) technologies have become essential tools for the diagnosis and preoperative staging assessment of bladder cancer. However, establishing a precise system suitable for clinical application remains a significant challenge, and accurate prediction of bladder cancer staging is not yet possible. Therefore, exploring a system for the precise diagnosis of preoperative staging of bladder cancer using ultrasound contrast enhancement or a combination of ultrasound contrast enhancement and MRI is of great importance. The applicant has previously demonstrated the accuracy of multimodal data analysis in the diagnosis and prediction of malignant tumors. Preliminary results from this study have shown that ultrasound contrast enhancement has a high diagnostic efficacy for the preoperative staging assessment of bladder cancer, with a high area under the curve (AUC) of 0.88, sensitivity of 83.3%, specificity of 92.5%, and accuracy of 90.8%. In this project, the applicant intends to further expand the sample size and, based on the combination of ultrasound contrast enhancement and MRI, develop a precise diagnostic system for the preoperative staging of bladder cancer to aid clinical treatment decisions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contrast-enhanced Ultrasonography | – | Diagnostic Test: Contrast Enhanced Ultrasound (CEUS)To evaluate the diagnostic accuracy of CEUS for the preoperative staging of bladder cancer, which would benefit the implementation of efficient therapeutic strategies. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who have a histologically or cytologically confirmed diagnosis of primary bladder cancer
Key inclusion criteria (3 listed)
- (a) eligible patients should be 18-year-old or older;
- (b) patients should have a histologically or cytologically confirmed diagnosis of primary bladder cancer;
- (c) patients should not have had any surgery, chemotherapy, immunotherapy, or any therapy before CEUS diagnosis.
Key exclusion criteria (3 listed)
- (a) participants with confirmed to have no carcinoma of the bladder;
- (b) participants with previous pelvic surgery, who had undergone therapy, any bladder surgery, or had received chemotherapy, radiotherapy or immunotherapy;
- (c) participants diagnosed with tumor recurrence or metastasis; (d) participants who were allergic to ultrasound contrast agents or could not tolerate CEUS examination, for instance, with recent myocardial infarction, angina pectoris, cardiac insufficiency, severe cardiac arrhythmia, a right/left cardiac shunt, severe pulmonary hypertension, uncontrolled systemic hypertension, acute respiratory distress syndrome, or chronic obstructive pulmonary disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast Enhanced Ultrasound (CEUS)Contrast Enhanced Ultrasound (CEUS) refers to the observation under ultrasound after the injection of ultrasound contrast agents, such as SonoVue or Lumason. | Diagnostic test | Contrast-enhanced Ultrasonography |
Primary outcome
Detection of Muscle Invasion in Bladder Cancer
Time frame: within 3 minutes
To evaluate the preoperative staging of bladder cancer，whether it is non-muscle invasive bladder cancer (NMIBC) or muscle invasive bladder cancers (MIBC)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: Yes
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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.
Luo, Prof. study director
Department of Ultrasound in Medicine, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
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 Bladder Cancer and Staging, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 24 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ou, Dr. (020-34071020, ouqy5@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Muscle Invasion in Bladder Cancer (time frame: within 3 minutes). 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 24 Jan 2025.