NCT01562223Unknown不适用
Repeatability Assessment of Quantitative DCE-MRI and DWI: A Multicenter Study of Functional Imaging Standardization in the Prostate
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Repeatability assessment of DCE-MRI metrics Ktrans and blood-normalized initial area under the gadolinium curve (IAUGC90bn) and the DWI metric D(t)
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Repeatability Assessment
Experimental
Gadolinium motexafin gadolinium All participants will undergo two consecutive DCE-MRI and DWI scans per same imaging parameters and subsequent comparison for repeatability.
干预措施: motexafin gadolinium (Other)
结局指标
主要结局
Repeatability assessment of DCE-MRI metrics Ktrans and blood-normalized initial area under the gadolinium curve (IAUGC90bn) and the DWI metric D(t)
时间窗: 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
次要结局
- 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)
研究者
研究点 (1)
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