Studying Repeated DCE-MRI and DWI in Patients Diagnosed With Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Other: motexafin gadolinium
- Registration Number
- NCT01562223
- Lead Sponsor
- American College of Radiology Imaging Network
- 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)
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Repeatability Assessment motexafin gadolinium Gadolinium motexafin gadolinium All participants will undergo two consecutive DCE-MRI and DWI scans per same imaging parameters and subsequent comparison for repeatability.
- Primary Outcome Measures
Name Time Method Repeatability assessment of DCE-MRI metrics Ktrans and blood-normalized initial area under the gadolinium curve (IAUGC90bn) and the DWI metric D(t) 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 Outcome Measures
Name Time Method 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 The repeatability coefficient (RC) and its 95% confidence interval (CI) will be estimated for each metric using the method of Barnhart and Barboriak, 2009
Comparison between T1-dependent or T1-independent methods for gadolinium quantification produce differing values for the RC for Ktrans 2 to 14 Days The repeatability coefficient (RC) and its 95% confidence interval (CI) will be estimated for each metric ktrans\] and each method \[ independent and dependent\] using the method of Barnhart and Barboriak, 2009
Trial Locations
- Locations (1)
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States