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

Primary Purpose

Urinary Bladder Tumour, MRI, Invasion

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urinary Bladder Tumour focused on measuring 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)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU clermont-ferrand

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Comparison between MRI versus anatomopathology report in bladder cancer

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Efficacy of neoadjuvant chemotherapy on muscle invasive bladder tumour
Determine the number of cystectomy parts without tumour residue after neoadjuvant chemotherapy

Full Information

First Posted
July 12, 2022
Last Updated
August 30, 2022
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT05464576
Brief Title
Tumor Staging T of Bladder Tumours: Correlation of MRI and Anatomopathologic Analysis
Acronym
IRMAA
Official Title
Tumor Staging T of Bladder Tumours: Correlation of MRI and Anatomopathologic Analysis.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants receive the same intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Comparison between MRI versus anatomopathology report in bladder cancer
Arm Type
Other
Arm Description
Comparison of MRI and anatomopathology on urinary bladder tumour after transurethral resection of the bladder or cystectomy (for patients with an invasive bladder cancer.
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI
Intervention Description
Using the MRI in the diagnosis of the bladder cancer (invasive or not)
Primary Outcome Measure Information:
Title
Non inferiority of the MRI compared to TURB in determining the degree of tumour infiltration
Description
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 month
Secondary Outcome Measure Information:
Title
Non inferiority of MRI versus anatomopathological report of the cystectomy
Description
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 month
Title
Efficacy of neoadjuvant chemotherapy on muscle invasive bladder tumour
Description
Determine the number of cystectomy parts without tumour residue after neoadjuvant chemotherapy
Time Frame
through study completion, an average of 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Laclautre
Phone
334.73.754.963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent GUY
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU clermont-ferrand
City
Clermont-Ferrand
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Laurent Guy

12. IPD Sharing Statement

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

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