Medical Imaging in Bladder Tumors by MRI

Magnetic Resonance Imaging Clinical Trial

Official title:

Clinical Study on the Diagnostic and Predictive Value of MRI Multifunctional Imaging in Bladder Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06033040
• Other study ID #: SYSKY-2023-549-01
• Status: Recruiting
• Start date: August 15, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Yuan Luo, master
• Phone: 8618816791193
• Email: luoy289[@]mail2.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study prospectively included 178 patients with bladder neoplastic lesions who planned to undergo surgery (with or without preoperative neoadjuvant chemotherapy). Inclusion criteria: Patients with pathologically confirmed bladder cancer after radical or partial cystectomy or TURBT (< 2 weeks between surgical resection and imaging). Exclusion criteria: 1) Prior history of chemotherapy and/or radiotherapy; 2) No surgical resection; 3) The interval between surgical resection and imaging examination is > 2 weeks; 4) Obvious artifacts; 5)MRI scan contraindications. All subjects underwent pelvic MRI. Data was collected using a Siemens VIDA 3TMR scanner (Siemens Healthcare, Erlangen, Germany). All subjects underwent standardized scanning protocols. The obtained images are post-processed and the experimental results are analyzed statistically.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Clinical diagnosis of bladder neoplasm

2. Must undergo radical or partial cystectomy or TURBT surgery within 2 weeks between surgical resection and imaging

Exclusion Criteria:

1. A history of pelvic radiotherapy or chemotherapy;

2. Lack of pathological findings or no surgery;

3. The interval between surgical resection and imaging examination > 2 weeks;

4. Poor image quality due to poor coordination or motion artifacts;

5. MRI scan contraindications

Related Conditions & MeSH terms

• Bladder Tumor
• Magnetic Resonance Imaging
• Urinary Bladder Neoplasms

Intervention

Other:
• MRI
Functional sequence imaging (MDME, IVIM) sequences were added to the routine MRI scan of patients with bladder tumor

Locations

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

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	quantitative parameters by MRI	quantitative parameters by functional MRI	From the time the participants completed the MRI scan to the post-processing of the resulting images,assessed up to 2 months