Tumor Staging T of Bladder Tumours: Correlation of MRI and Anatomopathologic Analysis

NCT05464576 | Unknown

• 2 other identifiers: AOI 2021 GUY2022-A00400-43
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Urinary bladder tumors with a frequency of 13000 new cases a year, have a heterogeneity in terms of survival according to the stage of local flooding. This is an aggressive tumor because of the potential muscular infiltration. It seems important in this case (muscular invasion), to increase the global survival. The anatomopathological analysis of the TURB (biopsy byTrans-Urethral Resection of the Bladder) is actually the gold standard for the pathology of bladder tumor. No need an imaging to discuss about the small and non muscular invasive tumor. But in most cases, the use is to perform at last an ultrasound or a CT-Scan, specially for the invasive tumor. A lot of studies show that CT SCAN. is not the best way of investigation for the bladder muscle invasion. However, as in the prostate cancer with the PIRADS Score, the MRI can be useful for the bladder, thanks to the sequence improvement to the machine. The study from Panebianco 2018, starts to talk about the MRI in the urinary bladder cancer with new radiological terms. It creates a new score called VIRADS score (as the PIRADS score already used for the prostate cancer). But it is never compared with the results of the TURB. Our study compares the results of the MRI pre operative versus the pathology results on prospective analysis. Main objective : T tumoral score in urinary bladder tumor : MRI versus pathology results. Secondary objectives : the contribution of diffusion weighted MRI in the bladder neoplasm. Type of study : interventional study, prospective, mono centric, single arm, intent-to-treat

Conditions

Urinary Bladder Tumour; MRI; Invasion; Diagnosis

Keywords

Magnetic resonance imaging; MRI versus anatomopathology; Urinary bladder tumor; MRI diagnosis before TURB (Trans Urethral Resection of the Bladder); NIMBC (Non Invasive Muscle Bladder Cancer)

Outcome Measures

Primary Outcomes (1)

• Non inferiority of the MRI compared to TURB in determining the degree of tumour infiltration

  Compare the concordance between MRI and pathological analysis of the samples of the TURB in determining the degree of bladder tumour infiltration. The dependent variable of interest is the determination of the infiltrating character (or not) of the tumour on the anatomopathological examination of the RTUV. It will be confronted with the main explanatory variable, which is the determination of the invasive character (or not) of the tumour on the preoperative MRI.

  through study completion, up to 6 month

Secondary Outcomes (2)

• Non inferiority of MRI versus anatomopathological report of the cystectomy

  through study completion, an average of 6 month

• Efficacy of neoadjuvant chemotherapy on muscle invasive bladder tumour

  through study completion, an average of 6 month

Study Arms (1)

Comparison between MRI versus anatomopathology report in bladder cancer

OTHER

Comparison of MRI and anatomopathology on urinary bladder tumour after transurethral resection of the bladder or cystectomy (for patients with an invasive bladder cancer.

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

Using the MRI in the diagnosis of the bladder cancer (invasive or not)

Comparison between MRI versus anatomopathology report in bladder cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient, male or female, aged \>18ans
• Benefiting from Social Security
• Urinary bladder tumour confirmed on cystoscopy and requiring a TURB
• Understanding and reading French well
• Ability to give informed consent

You may not qualify if:

• Participation refusal
• MRI contraindication : pacemaker, heart valve, clips, stents, coils, non-MRI compatible defibrillators, neural or peripheral stimulator, cochlear implant, intraocular foreign body, claustrophobia
• Patient under guardianship, deprived of liberty, impaired understanding
• Pregnant/breastfeeding woman
• Allergy to gadolinium (contrast product necessary for carrying out the MRI), hypersensitivity to gadoteric acid or gadolinated contrast products, to meglumine
• Suspicion of an infectious disease such as schistosomiasis (differential diagnosis)
• Patient presenting with macroscopic clotting hematuria on the day of the MRI

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Disease; Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Laurent GUY

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants receive the same intervention

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 19, 2022
• Study Start: September 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: July 31, 2025
• Last Updated: September 2, 2022

Record last verified: 2022-07

Locations

FR (1)