Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525831
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Rein 3D PRINT MECHANICS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multimodal Imaging of the Biomechanical Properties of Kidney Tumors Feasibility Inter-modality Correspondence and Diagnostic Value
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Rein3DP-M
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None