NCT05464576 Tumor Staging T of Bladder Tumours: Correlation of MRI and Anatomopathologic Analysis
| NCT ID | NCT05464576 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Clermont-Ferrand |
| Condition | Urinary Bladder Tumour |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2022-09-14 |
| Primary Completion | 2028-03-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2022-09-14 with a primary completion date of 2028-03-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Laurent GUY
PRINCIPAL INVESTIGATOR
University Hospital, Clermont-Ferrand
Frequently Asked Questions
Who can join the NCT05464576 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Urinary Bladder Tumour. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05464576 currently recruiting?
Yes, NCT05464576 is actively recruiting participants. Contact the research team at promo_interne_drci@chu-clermontferrand.fr for enrollment information.
Where is the NCT05464576 trial being conducted?
This trial is being conducted at Clermont-Ferrand, France.
Who is sponsoring the NCT05464576 clinical trial?
NCT05464576 is sponsored by University Hospital, Clermont-Ferrand. The principal investigator is Laurent GUY at University Hospital, Clermont-Ferrand. The trial plans to enroll 150 participants.