Studying Repeated DCE-MRI and DWI in Patients Diagnosed With Prostate Cancer (A6701QIBA)

Tracking Information
First Submitted Date ICMJE	March 22, 2012
First Posted Date ICMJE	March 23, 2012
Last Update Posted Date	March 20, 2017
Study Start Date ICMJE	August 2012
Estimated Primary Completion Date	January 2018 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 23, 2013)	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 ]
Original Primary Outcome Measures ICMJE; (submitted: March 22, 2012)	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	Complete list of historical versions of study NCT01562223 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: January 23, 2013)	Test-retest performance, assessed by the RC of Ktrans, IAUGC90bn, and D(t), and measured by median pixel values of the prostate tumor [ Time Frame: 2 to 14 Days ]; Reader effect on the RC of DCE-MRI and DWI metrics for whole prostate and tumor nodule target lesion [ Time Frame: 2 to 14 Days ]; Comparison between T1-dependent or T1-independent methods for gadolinium quantification produce differing values for the RC for Ktrans [ Time Frame: 2 to 14 Days ]
Original Secondary Outcome Measures ICMJE; (submitted: March 22, 2012)	Test-retest performance, assessed by the RC of Ktrans, IAUGC90bn, and D(t), and measured by median pixel values of the prostate tumor; Reader effect on the RC of DCE-MRI and DWI metrics for whole prostate and tumor nodule target lesion; Comparison between T1-dependent or T1-independent methods for gadolinium quantification produce differing values for the RC for Ktrans
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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.
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
Condition ICMJE	Prostate Cancer
Intervention ICMJE	Other: motexafin gadolinium; Other Name: Gadolinium
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Active, not recruiting
Estimated Enrollment ICMJE; (submitted: March 22, 2012)	30
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	January 2019
Estimated Primary Completion Date	January 2018 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	DISEASE CHARACTERISTICS: Diagnosis of prostate adenocarcinoma by transrectal ultrasound (TRUS)-guided biopsy between 28 to 90 days prior to enrollment; Minimal tumor burden as defined by at least one of the following criteria: One single core with ≥ 50% cancer burden and ≥ 5 mm tumor length Two or more cores in the same prostate region, each with ≥ 30% cancer burden Three or more cores positive for prostate cancer (of any magnitude of cancer burden) in the same prostate region Gleason score of 7 or higher cancer burden Prostate-specific antigen (PSA) ≥ 10 ng/mL PATIENT CHARACTERISTICS: Able to tolerate magnetic resonance imaging (MRI) required by protocol, to be performed at an American College of Radiology Imaging Network (ACRIN)-qualified facility and scanner; Not suitable to undergo MRI or gadolinium-based contrast agent because of: Severe claustrophobia not relieved by oral anxiolytics per institutional standard practice Presence of MRI-incompatible metallic objects or implanted medical devices in body (including, but not limited to, non-MRI compatible metal objects, cardiac pacemaker, aneurysm clips, artificial heart valves with steel parts, or metal fragments in the eye or central nervous system) Renal failure, as determined by glomerular filtration rate (GFR) < 30 mL/min based on a serum creatinine level obtained within 48 hours prior to enrollment Weight greater than that allowable by the MRI table, per local institutional practice PRIOR CONCURRENT THERAPY: No anti-androgenic therapy within 30 days prior to enrollment; No prior external-beam radiotherapy, proton radiotherapy, or brachytherapy to the prostate; No prior hip replacement or other major pelvic surgery
Sex/Gender	Sexes Eligible for Study: Male
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	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 )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: Yes Plan Description: See ACRIN data Sharing Policy: https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx
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	Principal Investigator: Mark A. Rosen Abramson Cancer Center of the University of Pennsylvania
PRS Account	American College of Radiology Imaging Network
Verification Date	March 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP