Status:

RECRUITING

Preoperative Detection of Muscle Invasion in Bladder Cancer with Contrast-enhanced Ultrasonography

Lead Sponsor:

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Conditions:

Bladder Cancer

Eligibility:

All Genders

18-75 years

Brief Summary

To evaluate the diagnostic accuracy of CEUS for the preoperative staging of bladder cancer, which would benefit the implementation of efficient therapeutic strategies.

Detailed Description

Bladder cancer can be grouped into non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancers (MIBC), the latter displaying high aggressiveness, a high degree of malignancy, compli...

Eligibility Criteria

Inclusion

  • (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

  • (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.

Key Trial Info

Start Date :

April 1 2020

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2027

Estimated Enrollment :

1000 Patients enrolled

Trial Details

Trial ID

NCT05204108

Start Date

April 1 2020

End Date

December 31 2027

Last Update

January 13 2025

Active Locations (1)

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Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China, 510120