Clinical trial NCT06807008: A Novel Pathway to Detect Muscle-invasive Bladder Cancer Based on Integrated Clinical Features and VI-RADS Score on MRI
Official title: A Novel Pathway to Detect Muscle-invasive Bladder Cancer Based on Integrated Clinical Features and VI-RADS Score on MRI: Results of a Prospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscle Invasive Bladder Cancer
Keywords: Magnetic resonance imaging
VI-RADS
Muscle-invasive bladder cancer
Hematuria
Pathway
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This multicenter prospective observational study received formal approval from the Institutional Review Board and Ethics Committee of each participating center. All patients were informed of the experimental nature of this study and gave written informed consent. All patients with suspected BCa were referred to four different centers (Sapienza University of Rome \[center #1\], Istituto Nazionale Tumori "Regina Elena" in Rome \[center #2\], Azienda Ospedaliera Universitaria Santa Maria della Misericordia in Udine \[center #3\], and Azienda Ospedaliera Universitaria in Bologna \[center #4\]), between January 2020 and May 2021, and underwent bladder MRI.

Brief summary: This study investigates the clinical, pathological, and radiological features, including the Vesical Imaging-Reporting and Data System (VI-RADS) score, that correlate with muscle-invasive bladder cancer (MIBC). It found that VI-RADS scores, along with other factors, were independent predictors of muscle invasiveness.

Detailed description: The purpose of this study was to determine the clinical, pathological, and radiological features, including the Vesical Imaging-Reporting and Data System (VI-RADS) score, independently correlating with muscle-invasive bladder cancer (BCa), in a multicentric national setting. Patients with BCa suspicion were offered magnetic resonance imaging (MRI) before trans-urethral resection of bladder tumor (TURBT). According to VI-RADS, a cutoff of ≥ 3 or ≥ 4 was assumed to define muscle-invasive bladder cancer (MIBC). Trans-urethral resection of the tumor (TURBT) and/or cystectomy reports will be compared with preoperative VI-RADS scores to assess accuracy of MRI for discriminating between non-muscle-invasive versus MIBC. Performance will be assessed by ROC curve analysis. Two univariable and multivariable logistic regression models were implemented including clinical, pathological, radiological data, and VI-RADS categories to determine the variables with an independent effect on MIBC.

Eligibility criteria: Inclusion Criteria:

* a primary diagnosis of bladder tumor,
* positive urinary cytology,
* suspected bladder neoplasm identifed by ultrasound of the urinary tract and/or cystoscopy and/or CT scan of the abdomen-pelvis.

Exclusion Criteria:

* history of prior urinary tract neoplasms,
* impossibility of achieving appropriate bladder distension,
* concomitant diagnosis of carcinoma in situ (CIS),
* no detectable lesion on MRI
* any contraindication to MRI (low renal function, MR unsafe medical devices etc.)
* any contraindication to spinal and general anesthesia.

Primary outcomes:
measure: The accuracy of the VI-RADS (Vesical Imaging-Reporting and Data System) score in predicting muscle-invasive bladder cancer (MIBC) preoperatively using MRI.
timeFrame: 6 weeks
Secondary outcomes:
measure: The correlation between specific clinical features and MIBC.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
city: Roma
country: Italy
facility: AOU Policlinico Umberto I - Sapienza University of Rome
city: Roma
country: Italy
facility: Regina Elena" National Cancer Institute
city: Udine
country: Italy
facility: Santa Maria della Misericordia University Hospital in Udine
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Riccardo Schiavina, MD
role: PRINCIPAL_INVESTIGATOR
References: