Studying Repeated DCE-MRI and DWI in Patients Diagnosed With Prostate Cancer (A6701QIBA)
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ClinicalTrials.gov Identifier: NCT01562223 |
Recruitment Status :
Active, not recruiting
First Posted : March 23, 2012
Last Update Posted : August 25, 2020
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Tracking Information | |||||
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First Submitted Date ICMJE | March 22, 2012 | ||||
First Posted Date ICMJE | March 23, 2012 | ||||
Last Update Posted Date | August 25, 2020 | ||||
Actual Study Start Date ICMJE | August 27, 2012 | ||||
Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE |
Repeatability assessment of DCE-MRI metrics Ktrans and blood-normalized initial area under the gadolinium curve (IAUGC90bn) and the DWI metric D(t) | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Studying Repeated DCE-MRI and DWI in Patients Diagnosed With Prostate Cancer | ||||
Official Title ICMJE | Repeatability Assessment of Quantitative DCE-MRI and DWI: A Multicenter Study of Functional Imaging Standardization in the Prostate | ||||
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. |
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Detailed Description | OBJECTIVES: Primary
Secondary
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE | Prostate Cancer | ||||
Intervention ICMJE | Other: motexafin gadolinium
Other Name: Gadolinium
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Study Arms ICMJE | Experimental: Repeatability Assessment
Gadolinium motexafin gadolinium All participants will undergo two consecutive DCE-MRI and DWI scans per same imaging parameters and subsequent comparison for repeatability.
Intervention: Other: motexafin gadolinium
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
30 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 2021 | ||||
Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01562223 | ||||
Other Study ID Numbers ICMJE | CDR0000728901 ACRIN-6701 ( Other Identifier: ACRIN Foundation ) U01CA080098 ( U.S. NIH Grant/Contract ) U01CA079778 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Responsible Party | American College of Radiology Imaging Network | ||||
Study Sponsor ICMJE | American College of Radiology Imaging Network | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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PRS Account | American College of Radiology Imaging Network | ||||
Verification Date | August 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |