CHU de Bordeaux
Bordeaux, 33076, France
Location status: Recruiting
Location contact
Eva FOURAGE, Dr
CONTACT
NCT Number: NCT06525831
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Bordeaux, 33076, France
Location status: Recruiting
Eva FOURAGE, Dr
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Imaging acquisition
Imaging acquisition
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.
Time frame: Between Day 0 and Month 4
Researh of the highest possible value (maximum = 1).
Time frame: Between Day 0 and Month 4
Measure based on a 5-point ordinal qualitative scale
Time frame: Between Day 0 and Month 4
Calculation using the contrast-to-noise ratio
Time frame: Between Day 0 and Month 4
Calculation using the signal-to-noise ratio
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 :
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).
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.
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.
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.
Contact information is provided by the study sponsor or research team.
University Hospital, Bordeaux
Other
Multimodal Imaging of the Biomechanical Properties of Kidney Tumors: Feasibility, Inter-modality Correspondence and Diagnostic Value
Acronym: Rein3DP-M
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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