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

NCT05204108 | Recruiting

• 1 other identifier: SYSEC-KY-KS-2021-321
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

Bladder Cancer; Contrast-enhanced Ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients who have a histologically or cytologically confirmed diagnosis of primary bladder cancer

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Baoming Luo, master

  Department of Ultrasound in Medicine, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiyun Ou, bachelor

CONTACT

020-34071020; ouqy5@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start: April 1, 2020
• Primary Completion: September 1, 2021
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)