Repeatability Assessment of Quantitative DCE-MRI and DWI: A Multicenter Study of Functional Imaging Standardization in the Prostate
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Repeatability assessment of DCE-MRI metrics Ktrans and blood-normalized initial area under the gadolinium curve (IAUGC90bn) and the DWI metric D(t)
Study Overview
Brief Summary
RATIONALE: Diagnostic procedures, such as dynamic contrast-enhanced magnetic resonance imaging or DCE-MRI and diffusion-weighted imaging or DWI, may provide images of prostate cancer or any cancer that remains after biopsy.
PURPOSE: This trial studies repeated DCE-MRI and DWI in patients diagnosed with prostate cancer.
Detailed Description
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)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Repeatability assessment of DCE-MRI metrics Ktrans and blood-normalized initial area under the gadolinium curve (IAUGC90bn) and the DWI metric D(t)
Time Frame: 2 to 14 Days
The repeatability coefficient (RC) and its 95% confidence interval (CI) will be estimated for each metric \[ ktrans, IAUGC90bn\] using the method of Barnhart and Barboriak, 2009
Secondary Outcomes
- Test-retest performance, assessed by the RC of Ktrans, IAUGC90bn, and D(t), and measured by median pixel values of the prostate tumor(2 to 14 Days)
- Comparison between T1-dependent or T1-independent methods for gadolinium quantification produce differing values for the RC for Ktrans(2 to 14 Days)
