Medical Imaging in Bladder Tumors by MRI

NCT06033040 | Unknown

• 1 other identifier: SYSKY-2023-549-01
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Tumor; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

MRI OTHER

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

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with bladder neoplasm planned to undergo surgery

You may qualify if:

• Clinical diagnosis of bladder neoplasm
• Must undergo radical or partial cystectomy or TURBT surgery within 2 weeks between surgical resection and imaging

You may not qualify if:

• A history of pelvic radiotherapy or chemotherapy;
• Lack of pathological findings or no surgery;
• The interval between surgical resection and imaging examination \> 2 weeks;
• Poor image quality due to poor coordination or motion artifacts;
• MRI scan contraindications

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, 510000, 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

Central Study Contacts

Yuan Luo, master

CONTACT

8618816791193; luoy289@mail2.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: September 13, 2023
• Study Start: August 15, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

CN (1)