Kidney CancerRein3DP-MNCT06525831
Rein 3D PRINT MECHANICS
A study testing MR-elastography exam and Ultrasound exam in people with Kidney Cancer, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- MR-elastography exam and Ultrasound exam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 7 Mar 2025to 7 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux
Bordeaux, 33076
Eva FOURAGE, Dr
About this study
Official title: Multimodal Imaging of the Biomechanical Properties of Kidney Tumors: Feasibility, Inter-modality Correspondence and Diagnostic Value
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).
Read the detailed description
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.
- Conditions
- Kidney Cancer
- Being tested
- MR-elastography exam, Ultrasound exam
- Keywords
- Renal-Cell Carcinoma, Renal Elasticity, Biomarkers, Ultrasound, CT-scan, Magnetic Resonance Imaging, AFRI, Diffusion weighted imaging
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-elastography examDiagnostic test
Imaging acquisition
Ultrasound examDiagnostic test
Imaging acquisition
| Study group | Role | What they receive |
|---|---|---|
| Patient with kidney cancer surgery | Experimental | 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 Receives: Diagnostic Test: MR-elastography exam; Diagnostic Test: Ultrasound exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Between Day 0 and Month 4
Secondary outcomes (9)
Measure of Spearman's rho
Researh of the highest possible value (maximum = 1).
Measured: Between Day 0 and Month 4
Measure of the qualitative assessment
Measure based on a 5-point ordinal qualitative scale
Measured: Between Day 0 and Month 4
Measure of the contrast
Calculation using the contrast-to-noise ratio
Measured: Between Day 0 and Month 4
Measure of the noise
Calculation using the signal-to-noise ratio
Measured: Between Day 0 and Month 4
Identification of imaging faisability limiting factors
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
Measured: Between Day 0 and Month 4
Evaluation of imaging repetabiliy limiting factors
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).
Measured: Between Day 0 and Month 4
identification of decorrelation situations and potential bias between biomechanical properties obtained by hardness measurements in the different imaging modalities
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.
Measured: Between Day 0 and Month 4
Carry out associations between histological categorical variables and numerical elasticity variables
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.
Measured: Between Day 0 and Month 4
Measure of the accuracy
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.
Measured: Between Day 0 and Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start7 Mar 2025
- Primary completion7 May 2027 (estimated)
- Study completion7 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The participants will undergo a Magnetic Resonance-elastography and Ultrasound exams for the research.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Sophia Genetics SAS
- Responsible party
- Sponsor
- Investigators
- FOURAGE EVA, Dr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525831
- Sponsor's protocol ID
- CHUBX 2022/11
- Acronym
- Rein3DP-M
- Status last verified
- Jun 2025
- First submitted
- 11 Jul 2024
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ronca 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.
PubMed 42418537
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Imaging of the Biomechanical Properties of Kidney Tumors: Feasibility, Inter-modality Correspondence and Diagnostic Value
- ClinicalTrials.gov ID
- NCT06525831
- Acronym / sponsor ID
- Rein3DP-M / CHUBX 2022/11
- Conditions
- Kidney Cancer
- Keywords
- Renal-Cell Carcinoma, Renal Elasticity, Biomarkers, Ultrasound, CT-scan, Magnetic Resonance Imaging, AFRI, Diffusion weighted imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Sophia Genetics SAS
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 7 May 2027 (estimated)
- Study completion
- 7 May 2027 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The participants will undergo a Magnetic Resonance-elastography and Ultrasound exams for the research.
| Arm | Type | Receives |
|---|---|---|
| Patient with kidney cancer surgery | Experimental | Diagnostic Test: MR-elastography exam, Diagnostic Test: Ultrasound examthe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR-elastography examImaging acquisition | Diagnostic test | Patient with kidney cancer surgery |
| Ultrasound examImaging acquisition | Diagnostic test | Patient with kidney cancer surgery |
Primary outcome
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.
9 secondary outcomes
Measure of Spearman's rho
Time frame: Between Day 0 and Month 4
Measure of the qualitative assessment
Time frame: Between Day 0 and Month 4
Measure of the contrast
Time frame: Between Day 0 and Month 4
Measure of the noise
Time frame: Between Day 0 and Month 4
Identification of imaging faisability limiting factors
Time frame: Between Day 0 and Month 4
Evaluation of imaging repetabiliy limiting factors
Time frame: Between Day 0 and Month 4
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
Carry out associations between histological categorical variables and numerical elasticity variables
Time frame: Between Day 0 and Month 4
Measure of the accuracy
Time frame: Between Day 0 and Month 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Derived from this study: PubMed 42418537Ronca 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
FOURAGE EVA, Dr principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR-elastography exam and Ultrasound exam in people with Kidney Cancer, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact FOURAGE EVA, Dr (0033556795679, eva.fourage@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the root mean square error (RMSE) (time frame: Between Day 0 and Month 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06525831, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.