Medical Imaging in Bladder Tumors by MRI

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

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.

Study Overview

• Status: Recruiting
• Conditions: Magnetic Resonance Imaging; Bladder Tumor
• Intervention / Treatment: Other: MRI

• Study Type: Observational
• Enrollment (Estimated): 178

Contacts and Locations

• Study Contact: Name: Yuan Luo, master; Phone Number: 8618816791193; Email: luoy289@mail2.sysu.edu.cn

Study Locations

• China
  • Guang Dong
    • Guangzhou, Guang Dong, China, 510000
      • Recruiting
      • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
      • Contact: Yuan Luo; Phone Number: 18816791193; Email: luoy289@mail2.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with bladder neoplasm planned to undergo surgery

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 27, 2023
• First Submitted That Met QC Criteria: September 4, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: SYSKY-2023-549-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No