Rein 3D PRINT MECHANICS
NCT Number: NCT06525831
Acronym: Rein3DP-M
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Kidney Cancer
Interventions: DIAGNOSTIC_TEST: MR-elastography exam|DIAGNOSTIC_TEST: Ultrasound exam
Sponsor: University Hospital, Bordeaux
Collaborators: Sophia Genetics SAS
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-17
Completion Date: 2026-07-17
Locations: CHU de Bordeaux, Bordeaux, 33076, France

Summary:
The goal of this innovative project is to evaluate the correspondence between several imaging modalities for characterizing the elasticity of healthy and pathological renal tissue which could help improve the realism of 3D prints used by urological surgeons and allow the identification of new, complementary imaging biomarkers. The main objective is to develop a predictive model of the biomechanical properties of normal and pathological kidney tissue, as assessed by the reference method (Magnetic Resonance (MR)-elastography).

Primary Outcome Measures: Measurement of the root mean square error (RMSE), The aim is to successfully predict μMRE from dCT-, dCT40s, dCT90s, dCT10min (naming μCT the scan model prediction) with the lowest possible error., Between Day 0 and Month 4
Secondary Outcome Measures: Measure of Spearman's rho, Researh of the highest possible value (maximum = 1)., Between Day 0 and Month 4|Measure of the qualitative assessment, Measure based on a 5-point ordinal qualitative scale, Between Day 0 and Month 4|Measure of the contrast, Calculation using the contrast-to-noise ratio, Between Day 0 and Month 4|Measure of the noise, Calculation using the signal-to-noise ratio, Between Day 0 and Month 4|Identification of imaging faisability limiting factors, Evaluation of the number of situations where the examination has no clinical diagnostic value and associations with potential limiting factors by using a composite criteria including :

* body mass index
* sarcopenia,
* lesion location
* lesion size
* lesion architecture, Between Day 0 and Month 4|Evaluation of imaging repetabiliy limiting factors, Measurement of the intra-class correlation coefficients and Bland-Altmann plot traces.

The aim is for the intra-class score to be as high as possible (maximum = 1, ideally \>0.90)., Between Day 0 and Month 4|identification of decorrelation situations and potential bias between biomechanical properties obtained by hardness measurements in the different imaging modalities, Visual measurement for each patient and anatomical situation with possible matching, point clouds with in X the hardness obtained by one imaging modality and in Y the hardness obtained by another imaging modality. The descriptive characteristics of the points (voxel or patient segmentation) with decorrelation will then be analyzed., Between Day 0 and Month 4|Carry out associations between histological categorical variables and numerical elasticity variables, The measurement will be based on associations between categorical histological and numerical elasticity variables, with area under the ROC curve comparisons or cut-off identification where appropriate.

Malignant/benign character (binary variable) and histological type (non- ordinal categorical variable) will be assessed as part of routine care by the pathologist., Between Day 0 and Month 4|Verification of correlation between actual hardness and hardness assessed by the various imaging methods, carried out directly on a fragment of the fresh surgical specimen, The actual hardness in kPa will be assessed by the physician in the immediate post-operative period on the fragment of the fresh surgical specimen, using a destructive method which measures a tissue's resistance to compression. The tissue will be subjected to increasing compression until it breaks.

The value wil be compared with data obtained by imaging., Between Day 0 and Month 4