Ultrasound Contrast-Enhanced Accurate Diagnosis of Preoperative Staging of Bladder Cancer

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

RECRUITING

Total Enrollment

480 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bladder Cancer Staging Contrast Enhanced Ultrasound

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Contrast Enhanced Ultrasound (CEUS)

Intervention Type DIAGNOSTIC_TEST

Contrast Enhanced Ultrasound (CEUS) refers to the observation under ultrasound after the injection of ultrasound contrast agents, such as SonoVue or Lumason.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No