3D-printed kidney models with realistic tissue stiffness
Multimodal Imaging of the Biomechanical Properties of Kidney Tumors: Feasibility, Inter-modality Correspondence and Diagnostic Value
We will test whether MRI and ultrasound measurements can predict the stiffness of healthy and cancerous kidney tissue in adults scheduled for nephrectomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT06525831 on ClinicalTrials.gov |
What this trial studies
This single-center interventional project will enroll 50 adults scheduled for nephrectomy for kidney cancer who will undergo MR-elastography, diffusion-weighted MR-elastography sequences, and ultrasound before surgery. CT scans used for 3D model generation will be compared with MR and ultrasound elasticity measures, and resected tissue fragments will undergo mechanical testing as the reference standard. Imaging and ex vivo mechanical data will be combined to build a predictive model of renal biomechanical properties and to search for complementary imaging biomarkers. The work aims to improve the realism of 3D-printed models for surgical planning and to refine noninvasive imaging characterization of renal tumors.
Who should consider this trial
Good fit: Adults (≥18) scheduled for surgical nephrectomy for a kidney tumor at CHU de Bordeaux who can undergo MRI and ultrasound, have or will have a CT scan, and provide informed consent.
Not a fit: Patients who are pregnant, have contraindications to MRI or gadolinium, recent biopsy within 15 days, BMI ≥30 kg/m², thoracolumbar hardware, or other listed exclusions are unlikely to be eligible and therefore may not benefit from the study.
Why it matters
Potential benefit: If successful, this approach could make 3D-printed kidney models more realistic for surgeons and provide imaging biomarkers that better characterize tumors before surgery.
How similar studies have performed: Elastography methods have shown clinical value in liver and some renal research, but direct multimodal correlation with mechanical testing and application to improve 3D print realism for kidney tumors is largely novel.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Bordeaux
- CHU de Bordeaux — Bordeaux, France (Recruiting)
Study contacts
- Principal investigator: FOURAGE EVA, Dr — University Hospital, Bordeaux
- Study coordinator: FOURAGE EVA, Dr
- Email: eva.fourage@chu-bordeaux.fr
- Phone: 0033556795679
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.