Trial Information

Repeatability Assessment of Quantitative DCE-MRI and DWI: A Multicenter Study of Functional Imaging Standardization in the Prostate

OBJECTIVES:

Primary

- Determine the test-retest performance, assessed by the repeatability coefficient [RC]
of K^trans and gadolinium curve (IAUGC90^bn) and measured by median pixel values of the
whole prostate.

- Determine the test-retest performance, assessed by the RC of diffusion-weighted imaging
(DWI) metrics D(t) and measured by median pixel values of the whole prostate.

Secondary

- Determine the test-retest performance, assessed by RC of K^trans, IAUGC90^bn, and D(t),
and measured by median pixel values of the dominant prostate tumor.

- Determine the effect of reader on the RC of dynamic contrast-enhanced magnetic
resonance imaging (DCE-MRI) and DWI metrics for whole prostate and tumor nodule target
lesion.

- Determine whether T1-dependent or T1-independent methods for gadolinium quantification
in DCE-MRI studies produce differing values for the RC for K^trans and IAUGC90^bn.

- Explore the correlation between DCE-MRI and DWI metrics for both whole prostate and
dominant tumor nodule as target lesions. (Exploratory)

- Determine whether the "coffee break" approach toward test-retest analysis of
quantitative DWI provides a reasonable estimate of the RC of D(t)of the whole prostate,
using as the gold standard the RC of D(t) obtained between the two separate MRI visits.
(Exploratory)

OUTLINE: This is a multicenter study. Patients are stratified according to MRI vendor used
(Siemens vs GE vs Philips).

Patients receive gadolinium-based contrast IV and undergo DCE-MRI* and DWI 2 imaging at 2-14
days apart prior to treatment initiation. A central reader evaluation of the 2 successive
scans is then conducted.

NOTE: *At the discretion of the participating sites, the initial MRI visit (MRI SCAN 1) may
be supplemented with endorectal-coil imaging per institutional norms.