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

Phase 1
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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



- 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.


- 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

- 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.

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.

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


- 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


- No anti-androgenic therapy within 30 days prior to enrollment

- No prior external-beam radiotherapy, proton radiotherapy, or brachytherapy to the

- No prior hip replacement or other major pelvic surgery

Type of Study:


Study Design:

Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Repeatability assessment of DCE-MRI metrics Ktrans and blood-normalized initial area under the gadolinium curve (IAUGC90bn) and the DWI metric D(t)

Outcome Time Frame:

2 to 14 Days

Safety Issue:


Principal Investigator

Mark A. Rosen

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania


United States: NCI CIP

Study ID:




Start Date:

August 2012

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage IIA prostate cancer
  • stage IIB prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • adenocarcinoma of the prostate
  • Prostatic Neoplasms



Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104