3D-printed kidney models with realistic tissue stiffness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.