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

Sponsor

American College of Radiology Imaging Network (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01562223

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

123.1

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Other: motexafin gadolinium	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Repeatability Assessment of Quantitative DCE-MRI and DWI: A Multicenter Study of Functional Imaging Standardization in the Prostate

Actual Study Start Date :

Aug 27, 2012

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: motexafin gadolinium Other Names: Gadolinium

Arm

Intervention/Treatment

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.

Other: motexafin gadolinium

Other Names:

Gadolinium

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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