Clinical trial NCT06525831: Rein 3D PRINT MECHANICS
Official title: Multimodal Imaging of the Biomechanical Properties of Kidney Tumors: Feasibility, Inter-modality Correspondence and Diagnostic Value
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Kidney Cancer
Keywords: Renal-Cell Carcinoma
Renal Elasticity
Biomarkers
Ultrasound
CT-scan
Magnetic Resonance Imaging
AFRI
Diffusion weighted imaging
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Sophia Genetics SAS
First posted: 2024-07-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The participants will undergo a Magnetic Resonance-elastography and Ultrasound exams for the research.
Primary purpose: DIAGNOSTIC

Brief 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).

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.

Eligibility criteria: 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 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

Primary outcomes:
measure: Measurement of the root mean square error (RMSE)
timeFrame: Between Day 0 and Month 4
Secondary outcomes:
measure: Measure of Spearman's rho
timeFrame: Between Day 0 and Month 4
measure: Measure of the qualitative assessment
timeFrame: Between Day 0 and Month 4
measure: Measure of the contrast
timeFrame: Between Day 0 and Month 4
measure: Measure of the noise
timeFrame: Between Day 0 and Month 4
measure: Identification of imaging faisability limiting factors
timeFrame: Between Day 0 and Month 4
measure: Evaluation of imaging repetabiliy limiting factors
timeFrame: Between Day 0 and Month 4
measure: identification of decorrelation situations and potential bias between biomechanical properties obtained by hardness measurements in the different imaging modalities
timeFrame: Between Day 0 and Month 4
measure: Carry out associations between histological categorical variables and numerical elasticity variables
timeFrame: Between Day 0 and Month 4
measure: 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
timeFrame: Between Day 0 and Month 4
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: JAMBON EVA, Dr
role: PRINCIPAL_INVESTIGATOR
References: