Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04251481 |
Other study ID # |
18-01454 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 16, 2019 |
Est. completion date |
October 2024 |
Study information
Verified date |
March 2024 |
Source |
NYU Langone Health |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The proposed study is to investigate the feasibility of using quantitative diffusion MRI
(dMRI) methods for accurate and comprehensive assessment of treatment response. dMRI is a
powerful tool to probe treatment-induced change in tumors. It is a unique in vivo imaging
technique sensitive to cellular microstructures at the scale of water diffusion length on the
order of a few microns. Previous studies have shown that both diffusion coefficient D and
diffusional kurtosis coefficient K are promising imaging markers of (i) cell viability which
can be used for evaluation of early treatment response. However, it is often underappreciated
that these dMRI metrics are not fixed constants, but rather functions of the diffusion time
t, D(t) and K(t); their t-dependency is determined by tissue properties, such as cell size
and membrane permeability of tissue. D(t) and K(t) of tumors can vary substantially depending
on t in the range of diffusion times (30-100 ms) typically used in clinical scan.
Description:
This study will investigate the t-dependency of dMRI over a range of diffusion times (30-500
ms) to determine an optimal diffusion time for treatment response assessment when only one
diffusion time needs to be used, particularly in routine clinical studies. Furthermore, the
data with multiple diffusion times will also be used to measure the water exchange time of
cancer cells. Exchange time has been studied using Dynamic Contrast Enhanced (DCE) MRI by
multiple groups including ours, and has been suggested as a marker of (ii) cellular
metabolism that regulates the ATP-dependent ion channels co-transporting water molecules. The
study will measure with dMRI, without using a contrast agent. The investigators also
demonstrated that Intra-Voxel Incoherent Motion (IVIM) MRI metrics (pseudo diffusivity, Dp;
perfusion fraction, fp), from multiple b-values at a fixed diffusion time, can be used to
assess the perfusion status of tumor and they are also associated with tumor interstitial
fluid pressure. The IVIM effect has been observed in various cancer types (33-39) and animal
tumor models. The product fp*Dp - a quantity including both blood volume and velocity
information - is considered as a parameter analogous to (iii) perfusion flow .