The primary objective of this study is to compare diffusion MRI derived parameters with the histological categorization of kidney tumours.
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are diffusion MRI derived parameters: FA, MD,
pseudodiffusion coefficients and perfusion fractions, that will be correlated
with the histological kidney cancer type (clear cell, chromophobe, cystic and
papillary renal cell carcinoma).
Secondary outcome
na.
Background summary
The arrangement of the microstructures of the kidneys, particularly tubules and
blood vessels, is closely associated with kidney function. With diffusion MRI
methods the diffusion of water molecules can be mapped. Water diffusion in
renal medullar tissue is restricted by the radial organization of tubules,
collecting ducts and vessels, and is therefore greater in the radial direction
than in other directions (hence, the diffusion is *anisotropic*). Recent
studies showed that anisotropy in de kidney medulla can be measured with
diffusion tensor imaging. Moreover, with fiber tractography the radial
orientation of the kidney structure can be visualized. Furthermore, intravoxel
incoherent motion (IVIM) analysis enables separation of different water motion
processes (e.g. perfusion and diffusion) based on differences in these
processes.
In a previous study, a comprehensive protocol for diffusion MRI imaging of the
kidneys, including DTI and IVIM analysis and visualization using tractography,
was developed and tested. The aim of this follow-up pilot study is to compare
diffusion MRI derived parameters to the histologically established kidney tumor
type. In this study both diffusion methods (DTI and IVIM) will be combined and
applied to a renal pathology for the first time, resulting in a broad range of
diffusion information. This information will, on the one hand, result in a
better understanding of the diffusion signal. On the other hand, it will be the
first step towards the use of diffusion MRI methods for in vivo categorization
of kidney tumor type.
Study objective
The primary objective of this study is to compare diffusion MRI derived
parameters with the histological categorization of kidney tumours.
Study design
Pilot study in 15 patients and 5 healthy volunteers.
Study burden and risks
Volunteers are subjected to a MRI scan of 45 minutes in a 3.0T MRI- scanner
(Philips Medical Systems, Best). There are no known risks associated with MRI,
beside temporary dizziness and claustrophobia. No contrast is needed. The
burden is relatively low.
Drienerloolaan 5
Enschede 7522NB
NL
Drienerloolaan 5
Enschede 7522NB
NL
Listed location countries
Age
Inclusion criteria
* Volunteers are healthy
* Volunteers and subjects are 18 year or older.
* Volunteers and subjects are capable and prepared to sign an informed consent.
* Subjects are eligible for radical nephrectomy
* Subjects are planned to undergo nephrectomy
Exclusion criteria
* Subjects and volunteers with contra-indications for MRI (like a pacemaker, claustrophobia).
* Subjects and volunteers with large (known) deviation in kidney anatomy (like horseshoe kidney).
* Refusal of volunteers and subjects to be informed of chance findings possibly relevant to their health.
* Subjects and volunteers with kidney pathologies (other than kidney tumor)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL52411.044.15 |
| OMON | NL-OMON24559 |