NCT06362330

Brief Summary

Accurate preoperative detection of muscle-invasive bladder cancer remains a clinical challenge. The investigators aimed to develop and validate a knowledge-guided causal diagnostic network for the detection of muscle-invasive bladder cancer with multiparametric magnetic resonance imaging(MRI).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 12, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

2.9 years

First QC Date

April 6, 2024

Last Update Submit

April 10, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Muscle-invasive bladder cancer

    The artificial intelligence diagnosis results, based on preoperative MRI, indicated muscle-invasive bladder cancer. Subsequently, this preoperative diagnosis was compared with the postoperative pathological diagnosis to evaluate the diagnostic performance of the artificial intelligence.

    one month

  • Non-muscle-invasive bladder cancer

    The artificial intelligence diagnosis results, based on preoperative MRI, indicated non-muscle-invasive bladder cancer. Subsequently, this preoperative diagnosis was compared with the postoperative pathological diagnosis to evaluate the diagnostic performance of the artificial intelligence.

    one month

Study Arms (2)

muscle-invasive bladder cancer

The postoperative pathology was muscle-invasive bladder cancer

Other: magnetic resonance imaging

non-muscle-invasive bladder cancer

The postoperative pathology was non-muscle-invasive bladder cancer

Other: magnetic resonance imaging

Interventions

Patients of bladder cancer underwent multiparameter magnetic resonance imaging before surgery

muscle-invasive bladder cancernon-muscle-invasive bladder cancer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Preoperative multi-parameter magnetic resonance imaging is essential to ascertain whether patients with bladder cancer exhibit muscular invasion, facilitating the selection of appropriate treatment options.

You may qualify if:

  • Urothelial carcinoma of the bladder confirmed by final histopathology ②Received a standard contrast-enhanced 3.0T mpMRI before surgery ③All tumors within patients included were resected and received pathologic examination separately

You may not qualify if:

  • ①Absence of surgical interventions
  • ②With inadequate image quality or with inadequate pathology for analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yu-Dong Zhang

Nanjing, 210029, China

RECRUITING

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2024

First Posted

April 12, 2024

Study Start

July 1, 2021

Primary Completion

May 30, 2024

Study Completion

June 30, 2024

Last Updated

April 12, 2024

Record last verified: 2024-04

Locations