Clinical trial · Interventional
Rein 3D PRINT MECHANICS
Multimodal Imaging of the Biomechanical Properties of Kidney Tumors: Feasibility, Inter-modality Correspondence and Diagnostic Value
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MR-elastography exam | Diagnostic Test | — | UNRESOLVED |
| Ultrasound exam | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patient with kidney cancer surgery
- description
- 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
- interventionNames
- Diagnostic Test: MR-elastography exam
- Diagnostic Test: Ultrasound exam
Primary outcomes (1)
- measure
- Measurement of the root mean square error (RMSE)
- timeFrame
- Between Day 0 and Month 4
- description
- The aim is to successfully predict μMRE from dCT-, dCT40s, dCT90s, dCT10min (naming μCT the scan model prediction) with the lowest possible error.
Secondary outcomes (9)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRonca M, Conforti P, Crombe A, Jaffredo M, Ricard S, Colin T, Yacoub M, Le Bras Y, Bernhard JC, Margue G, Fourage-Jambon E. Multimodal imaging to analyze the biomechanical properties of kidney tumors, evaluating feasibility, inter-modality correspondence, and diagnostic value (UroCCR-115). PLoS One. 2026 Jul 8;21(7):e0351477. doi: 10.1371/journal.pone.0351477. eCollection 2026. PMID 42418537