Tumor Staging T of Bladder Tumours: Correlation of MRI and Anatomopathologic Analysis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Non inferiority of the MRI compared to TURB in determining the degree of tumour infiltration
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Non inferiority of the MRI compared to TURB in determining the degree of tumour infiltration
时间窗: through study completion, up to 6 month
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.
次要结局
- Non inferiority of MRI versus anatomopathological report of the cystectomy(through study completion, an average of 6 month)
- Efficacy of neoadjuvant chemotherapy on muscle invasive bladder tumour(through study completion, an average of 6 month)