Multiparametric MRI for Diagnosing Small Renal Tumors (IRMK01)
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|ClinicalTrials.gov Identifier: NCT03470285|
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : January 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Renal Cancer||Procedure: Multiparametric MR imaging (mpMRI)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnostic Value of Multiparametric MR Imaging of Small Solid Renal Tumors (IRMK01)|
|Actual Study Start Date :||November 27, 2018|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||December 2021|
Patients with small solid renal tumor
In addition to the actual workflow for a patient presenting a renal tumor, patients will undergo an additional Multiparametric MR imaging (mpMRI).
Procedure: Multiparametric MR imaging (mpMRI)
The main objective of the study is to assess the diagnostic accuracy of mpMRI in small renal tumors. The study characteristics will comply with recommended methods (Quadas, Stard). The population to be included will be representative of patients who would benefit from mpMRI if it is demonstrated to be accurate. In this project, the MR protocol will used the conventional MR sequences either on 1.5 or 3T systems and do not require development. Each center may use their own protocol as long as it includes the mandatory sequences.
- Diagnostic accuracy of multiparametric MR imaging (mpMRI) [ Time Frame: For MRI results change from 1 day after urologist consultation up to 75 days, for pathology results change from 75 days after urologist consultation up to 3 months ]Index test will be the result from a dichotomized Likert Scale assessing the level of certainty of the malignant of benign nature as assessed by the radiologist on mpMRI images. The reference standard will be the pathology of the tumor (biopsy or surgery). The main measure of interest is the negative predictive value of a dichotomized Likert scale that is rating the level of certainty of the tumor nature diagnosis, based on mpMRI.
- Impact of mpMRI on the clinical management of renal tumors [ Time Frame: For MDC 1 up to 45 days after first urologist consultation, for MDC 2 up to 75 days after first urologist consultation ]Comparison between management plan decided during MDC1 before mpMRI and during MDC2 after results from mpMRI.
- Inter-observer reproducibility of mpMRI [ Time Frame: At inclusion ]
Comparison between results on Likert scale obtained from 3 readings. Independent assessments by 2 radiologists from the investigating center blind from each other and 1 central reviewer.
Likert scale (0, 1, 2, 3 or 4) assessing the level of certainty of the malignant or benign nature of the tumor, as assessed by the radiologist on mpMRI images, after coding each of the detailed MRI parameters.
- MR parameters in tumor subgroups based on histological findings [ Time Frame: For MRI results between from 1 day after urologist consultation up to 75 days, for pathology results from 75 days after urologist consultation up to 3 months ]MR parameters of each renal tumor subgroups assessed by pathology will be compare.
- Conclusion about the aggressiveness of clear cell renal cell carcinoma as assessed either by MR parameters or according to Fuhrman grade [ Time Frame: For MRI results between from 1 day after urologist consultation up to 75 days, for pathology results from 75 days after urologist consultation up to 3 months ]Conclusions regarding aggressiveness of clear renal cell carcinoma assessed either by MR parameters or according to Fuhrman grade will be compare.
- Occurrence of adverse events up to 6 months after mpMRI, initial surgery, biopsy or ablation [ Time Frame: From inclusion up to 6 months ]Occurrence assessment of adverse events following MRI, initial surgery, biopsy or ablation
- Ancillary RADIOMICS project will be conducted to validate new applied mathematics tools allowing semi-automatic quantitative evaluation of MR images [ Time Frame: For MRI results between from 1 day after urologist consultation up to 75 days. Algorithm results, probably 1 year after the end of the study ]A First step will be to provide a precise definition of the tumor volume and will allow to define a signature of each tumor. A statistical learning algorithm will be run in order to propose for each patient a quantification of the probability of malignancy of the tumor according to demographic data and imaging parameters.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470285
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