Clincosm LogoSign in Get a demo

Medical Imaging in Bladder Tumors by MRI

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06033040
Collaborator
(none)
178
Enrollment
1
Location
28.6
Anticipated Duration (Months)
6.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: MRI

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
178 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Clinical Study on the Diagnostic and Predictive Value of MRI Multifunctional Imaging in Bladder Tumors
Actual Study Start Date :
Aug 15, 2023
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Outcome Measures

Primary Outcome Measures

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

    quantitative parameters by functional MRI

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guang Dong China 510000

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT06033040
Other Study ID Numbers:
  • SYSKY-2023-549-01
First Posted:
Sep 13, 2023
Last Update Posted:
Sep 13, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Urinary Bladder Neoplasms

Study Results

No Results Posted as of Sep 13, 2023