Studying Repeated DCE-MRI and DWI in Patients Diagnosed With Prostate Cancer
NCT ID: NCT01562223
Last Updated: 2021-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2012-08-27
2022-12-31
Brief Summary
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PURPOSE: This trial studies repeated DCE-MRI and DWI in patients diagnosed with prostate cancer.
Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
motexafin gadolinium
Interventions
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motexafin gadolinium
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
American College of Radiology Imaging Network
NETWORK
Responsible Party
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Principal Investigators
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Mark A. Rosen
Role: PRINCIPAL_INVESTIGATOR
Abramson Cancer Center at Penn Medicine
Locations
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Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Related Links
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National Cancer Institute's clinical trials database
Other Identifiers
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