Diagnosis Clinical Trial
— IRMAAOfficial title:
Tumor Staging T of Bladder Tumours: Correlation of MRI and Anatomopathologic Analysis.
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
Status | Not yet recruiting |
Enrollment | 150 |
Est. completion date | July 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU clermont-ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Non inferiority of MRI versus anatomopathological report of the cystectomy | Compare the concordance between MRI and pathological analysis of the cystectomy on the presence or absence of tumour residue after neoadjuvant chemotherapy.
The dependent variable of interest is the determination of the presence (or not) of a tumour on the anatomopathological examination of the cystectomy. It will be confronted with the main explanatory variable, which is the determination of the presence (or not) of tumour on the post neoadjuvant chemotherapy MRI. |
through study completion, an average of 6 month | |
Secondary | Efficacy of neoadjuvant chemotherapy on muscle invasive bladder tumour | Determine the number of cystectomy parts without tumour residue after neoadjuvant chemotherapy | through study completion, an average of 6 month |
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