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

Bladder Cancer Clinical Trial

Official title:

Evaluation of the Preoperative Detection of Muscle Invasion in Bladder Cancer With Contrast-enhanced Ultrasonography: A Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05204108
• Other study ID #: SYSEC-KY-KS-2021-321
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: January 2022
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Qiyun Ou, bachelor
• Phone: 020-34071020
• Email: ouqy5[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 163
• Est. completion date: December 1, 2022
• Est. primary completion date: September 1, 2021
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	within 3 minutes