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NCT Number: NCT06525831

Rein 3D PRINT MECHANICS

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux

Bordeaux, 33076, France

Location status: Recruiting

Location contact

Eva FOURAGE, Dr

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MR-elastography exam

Diagnostic Test

Imaging acquisition

Ultrasound exam

Diagnostic Test

Imaging acquisition

Primary outcomes

  1. Measurement of the root mean square error (RMSE)

    Time frame: Between Day 0 and Month 4

    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

  1. Measure of Spearman's rho

    Time frame: Between Day 0 and Month 4

    Researh of the highest possible value (maximum = 1).

  2. Measure of the qualitative assessment

    Time frame: Between Day 0 and Month 4

    Measure based on a 5-point ordinal qualitative scale

  3. Measure of the contrast

    Time frame: Between Day 0 and Month 4

    Calculation using the contrast-to-noise ratio

  4. Measure of the noise

    Time frame: Between Day 0 and Month 4

    Calculation using the signal-to-noise ratio

  5. Identification of imaging faisability limiting factors

    Time frame: Between Day 0 and Month 4

    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
  6. Evaluation of imaging repetabiliy limiting factors

    Time frame: Between Day 0 and Month 4

    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).

  7. identification of decorrelation situations and potential bias between biomechanical properties obtained by hardness measurements in the different imaging modalities

    Time frame: Between Day 0 and Month 4

    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.

  8. Carry out associations between histological categorical variables and numerical elasticity variables

    Time frame: Between Day 0 and Month 4

    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.

  9. Measure of the accuracy

    Time frame: Between Day 0 and Month 4

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

FOURAGE EVA, Dr

CONTACT

[email protected]

0033556795679

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Sophia Genetics SAS

Registry information

Official study title

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

Acronym: Rein3DP-M

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 29, 2024
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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