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

Sun Yat-sen University

Status: Enrolling

Conditions: Bladder Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05204108

SYSEC-KY-KS-2021-321

Details and patient eligibility

About

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

Full 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, complicated treatment, high propensity to metastasis, and poor prognosis. Currently, the clinical feasibility and accuracy of preoperative detection of muscle invasion in bladder cancer with contrast-enhanced ultrasonography (CEUS) are unclear.

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

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 1 patient group

Contrast-enhanced Ultrasonography

Description:

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