NCT06525831

Brief 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 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Mar 2025May 2027

First Submitted

Initial submission to the registry

July 11, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

March 7, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2027

Last Updated

April 14, 2026

Status Verified

June 1, 2025

Enrollment Period

2.2 years

First QC Date

July 11, 2024

Last Update Submit

April 8, 2026

Conditions

Kidney Cancer

Keywords

Renal-Cell CarcinomaRenal ElasticityBiomarkersUltrasoundCT-scanMagnetic Resonance ImagingAFRIDiffusion weighted imaging

Outcome Measures

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.

    Between Day 0 and Month 4

Secondary Outcomes (9)

  • Measure of Spearman's rho

    Between Day 0 and Month 4

  • Measure of the qualitative assessment

    Between Day 0 and Month 4

  • Measure of the contrast

    Between Day 0 and Month 4

  • Measure of the noise

    Between Day 0 and Month 4

  • Identification of imaging faisability limiting factors

    Between Day 0 and Month 4

  • +4 more secondary outcomes

Study Arms (1)

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

Diagnostic Test: MR-elastography examDiagnostic Test: Ultrasound exam

Interventions

MR-elastography examDIAGNOSTIC_TEST

Imaging acquisition

Patient with kidney cancer surgery
Ultrasound examDIAGNOSTIC_TEST

Imaging acquisition

Patient with kidney cancer surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33076, France

RECRUITING

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • FOURAGE EVA, Dr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

FOURAGE EVA, Dr

CONTACT

0033556795679eva.fourage@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: The participants will undergo a Magnetic Resonance-elastography and Ultrasound exams for the research.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2024

First Posted

July 29, 2024

Study Start

March 7, 2025

Primary Completion (Estimated)

May 7, 2027

Study Completion (Estimated)

May 7, 2027

Last Updated

April 14, 2026

Record last verified: 2025-06

Locations

FR(1)