Rein 3D PRINT MECHANICS (Rein3DP-M)

Multimodal Imaging of the Biomechanical Properties of Kidney Tumors: Feasibility, Inter-modality Correspondence and Diagnostic Value

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).

Study Overview

• Status: Recruiting
• Conditions: Kidney Cancer
• Intervention / Treatment: Diagnostic test: MR-elastography exam; Diagnostic test: Ultrasound exam

Detailed Description

Medical imaging plays a key role in the diagnostic and therapeutic management of renal cell carcinomas. It can be used to confirm the presence of a tumor, localize it, suggest malignancy or even histological subtype, guide sampling, perform TNM staging, assist in surgical scheduling, monitor therapeutic efficacy in the event of systemic treatment, guide ablathermy procedures and look for relapses after curative treatments have ended. Imaging of kidney tumors relies on three complementary imaging modalities: ultrasound (US), Computed Tomography based on X-ray absorption (CT-scan) and magnetic resonance imaging (MRI). The most commonly performed examination remains the CT scan, which is used to print 3D models. However, the correlation between renal parenchyma densities and renal tumors (before and during the scan acquisition times after injection) and elasticity parameters measured by US and MRI has never been explored.

This trial aim to evaluate the correspondence between several imaging modalities for characterizing the elasticity of healthy and pathological kidney tissue. It will also improve the realism of 3D models used by surgeons, and identify new complementary imaging biomarkers.

To achieve this aim, 50 patients will undergo DWI -elastography (Diffusion Weigthed Imaging-elastography) and MR-elastography sequences, as well as an US before the surgery. After surgery, a fragment of the resected specimen will be used to perform mechanical tests to determine the real hardness of the tissue.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: FOURAGE EVA, Dr; Phone Number: 0033556795679; Email: eva.fourage@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France, 33076
    • Recruiting
    • CHU de Bordeaux
    • Contact: Eva FOURAGE, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients (≥ 18 years of age)
• Scheduled for surgical management with nephrectomy for kidney tumor in the urology department of Bordeaux University Hospital
• CT scan available or scheduled for surgery
• Consent expressed for integration of the UroCCR database
• Expressed consent for participation in the Rein 3D Print Mechanics study
• Patients affiliated or benefiting from social security system

Exclusion Criteria:

• - Pregnant or breast-feeding women
• Contraindication to MRI (Magnetic Resonance Imaging)
• Contraindication to injection of gadoline contrast agents
• Biopsy performed within 15 days prior to MRI, CT and ultrasound scans (risk of artifactual alteration, via iatrogenic hemorrhagic changes, of the biomechanical properties of the renal tumor and parenchyma).
• Presence of thoracolumbar arthrodesis material
• Obese patient (body mass index ≥ 30 kg/m²)
• Cystic renal tumors with solid component (corresponding to either parietal thickening or tumor bud) < 2 cm
• Necrotic renal tumors with solid component (corresponding to either parietal thickening or tumor bud) < 2 cm
• Ascites
• Person under legal protection
• Difficulty understanding and expressing in French

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient with kidney cancer surgery; the patients will have an additionnal MRI elastography and Ultrasound exams for the research. The exams will be performed between the inclusion of the patient and the day before the surgery. Both exams are non-invasive, without radiation	Diagnostic test: MR-elastography exam; Imaging acquisition; Diagnostic test: Ultrasound exam; Imaging acquisition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
Measure of the accuracy	Measure accordance between continuous scanner elasticity mapping (in kPa) and discrete elasticity mapping derived from density classes (necrosis, tissue, calcifications), assessed by Spearman's correlation coefficient and Bland-Altman analysis (bias and limits of agreement), with the objective being a high correlation and minimal bias.	Between Day 0 and Month 4

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Sophia Genetics SAS
• Investigators: Principal Investigator: FOURAGE EVA, Dr, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2025
• Primary Completion (Estimated): May 7, 2027
• Study Completion (Estimated): May 7, 2027

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Ultrasound; Magnetic Resonance Imaging; Biomarkers; Diffusion weighted imaging; CT-scan; Renal-Cell Carcinoma; Renal Elasticity; AFRI
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Carcinoma; Carcinoma, Renal Cell; Kidney Neoplasms
• Other Study ID Numbers: CHUBX 2022/11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No