Clinical trial NCT06775977: Ultrasound Contrast-Enhanced Accurate Diagnosis of Preoperative Staging of Bladder Cancer
Official title: Ultrasound Contrast-Enhanced Accurate Diagnosis of Preoperative Staging of Bladder Cancer: a Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Cancer
Staging
Contrast Enhanced Ultrasound
Keywords: Bladder Cancer
Contrast-Enhanced Ultrasonography
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who have a histologically or cytologically confirmed diagnosis of primary bladder cancer

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* (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.

Exclusion Criteria:

* (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.

Primary outcomes:
measure: Detection of Muscle Invasion in Bladder Cancer
timeFrame: within 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Department of Ultrasound in Medicine, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
name: Luo, Prof.
role: STUDY_DIRECTOR
References: