Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05464576
Other study ID # AOI 2021 GUY
Secondary ID 2022-A00400-43
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date July 31, 2025

Study information

Verified date July 2022
Source University Hospital, Clermont-Ferrand
Contact Lise Laclautre
Phone 334.73.754.963
Email promo_interne_drci@chu-clermontferrand.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

This is a single center study comparing MRI report to anatomopathological report in participants who were diagnosed with an urinary bladder tumour, histologically confirmed in routine care. Bladder tumours are frequent pathologies with 13,000 new cases per year in France. They can present various types of damage, from the most benign to the most serious stages, depending on the number, the extent of the lesions and their degree of infiltration (superficial or deeper). We also know that the shorter the treatment time, the better the final prognosis. An infiltrating lesion taken as soon as it is discovered considerably reduces the likelihood of progression. It is therefore necessary to improve patient care. Currently, when a bladder lesion is visualized by the urologist during the cystoscopy (examination during which the urologist notes the presence or absence of bladder lesion(s)), the only way to know its stage (and its degree of infiltration if applicable) which will determine the follow-up care, consists in carrying out an intervention called Trans Urethral Resection of the Bladder (TURB), in order to remove the lesions which will be analyzed in the anatomopathological laboratory. This analysis is the best interpretation of the tumour stage, carried out in accordance with the international standards, and the only way to have a diagnosis of tumour lesions. Indeed, to date, no imaging technique (ultrasound, scanner, etc.) makes it possible to obtain it. The CT scan of the urinary tract is currently only used to identify lesions of the upper urinary tract or lymph nodes. However, in recent years, these techniques have evolved considerably, and studies have shown that MRI seems to have the ability to determine the tumour stage of bladder lesions. Investigators propose to demonstrate the value of MRI in determining tumour infiltration compared to the anatomopathological analysis of samples taken during TURB. This would provide better patient care in human, pathological, economic and technical terms, by developing a more precise mapping of lesions in the bladder, reducing waiting times for results and therefore obtaining earlier diagnosis, a reduction in the number of consultations, hospitalizations, surgeries more or less morbid, examinations... Finally, this would potentially : - Reduce the number of cystoscopies (examination normally painless, but unpleasant and frequent) carried out before TURB but also throughout the monitoring following the TURB, - Detect very early infiltrating lesions in order to limit their potential extension before the cystectomy.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France CHU clermont-ferrand Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05889312 - Assessing Cancer Treatment Response to Therapy Using 18F-FSPG PET
Not yet recruiting NCT05845112 - Start Taking Action For TB Diagnosis
Completed NCT01194557 - Introducing Rapid Diagnostic Tests Into the Private Health Sector N/A
Completed NCT04257955 - COMMUNIcation and Patient Engagement at Diagnosis of PAncreatic CAncer
Recruiting NCT05698212 - Proof of Concept Study to Eval MetriDx Lab-developed Test to Identify Endometriosis-specific Bio Markers Phase 2
Recruiting NCT03372330 - Peripheral Artery Disease and Sepsis Outcomes N/A
Active, not recruiting NCT06134011 - A Multi-omics-based Metabolic Typing Study of Gastric Cancer
Recruiting NCT06289803 - The Application of Probe Confocal Laser Endomicroscopy in Pancreatic Tumor Surgery N/A
Not yet recruiting NCT06025240 - Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients
Completed NCT06185127 - Dexmedetomidine-ketamine Combination Versus Fentanyl-midazolam During Bronchoscopy Phase 3
Recruiting NCT05824442 - Evaluation of a New Multiplex Quantitative PCR Technique for the Diagnosis of Echinococcosis N/A
Not yet recruiting NCT06463223 - HIBOC = Hepatic Imaging Biomarkers in Obese Children
Not yet recruiting NCT06072820 - Analytical Evaluation of the Endotest® Diagnostic N/A
Recruiting NCT05587114 - Comparision of Various Biomarkers Between Peripheral and Pulmonary Blood
Recruiting NCT06230458 - Fractional Exhaled Nitric Oxide (FeNO)- Test as add-on Test in the Diagnostic Work-up of Asthma N/A
Not yet recruiting NCT05948410 - How Does the Mood of the Patients Change Before and After the Invasive Urodynamic Study?
Not yet recruiting NCT05947565 - Patient Position and Invasive Urodynamic Study Results in Males N/A
Not yet recruiting NCT04490746 - Identifcation of Biomarkers for Active Pulmonary Tuberculosis
Completed NCT03381131 - Chinese Version of Fibromyalgia Criteria and Severity Scales Study
Recruiting NCT05992519 - Diagnostic and Translational Values of Point-of-care Blood Eosinophils and Exhaled Nitric Oxide (FeNO) in People Referred by Primary Care for Suspected Asthma