Tumor Staging T of Bladder Tumours: Correlation of MRI and Anatomopathologic Analysis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
MRI
Diagnostic testUsing the MRI in the diagnosis of the bladder cancer (invasive or not)
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Comparison between MRI versus anatomopathology report in bladder cancerOther 1 intervention
Trial outcomes
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.
Time frame
through study completion, up to 6 monthSecondary outcomes
1
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.
Time frame
through study completion, an average of 6 month2
Efficacy of neoadjuvant chemotherapy on muscle invasive bladder tumour
Determine the number of cystectomy parts without tumour residue after neoadjuvant chemotherapy
Time frame
through study completion, an average of 6 monthSponsors and contacts
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Source ClinicalTrials.gov