Health TrialsbyHealthPanel

Rein 3D PRINT MECHANICS

ConditionKidney Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

- 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).

Trial design

Design model

Single group

Treatments tested in this trial

  • MR-elastography exam

    Diagnostic test

    Imaging acquisition

  • Ultrasound exam

    Diagnostic test

    Imaging acquisition

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Patient with kidney cancer surgeryExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Measurement of the root mean square error (RMSE)

The aim is to successfully predict μMRE from dCT-, dCT40s, dCT90s, dCT10min (naming μCT the scan model prediction) with the lowest possible error.

Time frame
Between Day 0 and Month 4

Secondary outcomes

1

Measure of Spearman's rho

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

Time frame
Between Day 0 and Month 4
2

Measure of the qualitative assessment

Measure based on a 5-point ordinal qualitative scale

Time frame
Between Day 0 and Month 4
3

Measure of the contrast

Calculation using the contrast-to-noise ratio

Time frame
Between Day 0 and Month 4
4

Measure of the noise

Calculation using the signal-to-noise ratio

Time frame
Between Day 0 and Month 4

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Bordeaux

Lead sponsor

Sophia Genetics SAS

Collaborator

Source ClinicalTrials.gov
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