Studying Repeated DCE-MRI and DWI in Patients Diagnosed With Prostate Cancer (A6701 QIBA)

This study is currently recruiting participants.
Verified January 2013 by American College of Radiology Imaging Network
Sponsor:
Collaborator:
Information provided by (Responsible Party):
American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:
NCT01562223
First received: March 22, 2012
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Prostate Cancer
Other: motexafin gadolinium
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by American College of Radiology Imaging Network:

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) [ Time Frame: 2 to 14 Days ] [ Designated as safety issue: No ]

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 [ Time Frame: 2 to 14 Days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2012
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Gadolinium

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562223

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mark Rosen, MD, PhD    215-662-3107      
Principal Investigator: Mark Rosen, MD, PhD         
Sponsors and Collaborators
American College of Radiology Imaging Network
Investigators
Principal Investigator: Mark A. Rosen Abramson Cancer Center of the University of Pennsylvania
  More Information

Additional Information:
No publications provided

Responsible Party: American College of Radiology Imaging Network
ClinicalTrials.gov Identifier: NCT01562223     History of Changes
Other Study ID Numbers: CDR0000728901, ACRIN-6701, CA80098
Study First Received: March 22, 2012
Last Updated: January 25, 2013
Health Authority: United States: NCI CIP

Keywords provided by American College of Radiology Imaging Network:
stage IIA prostate cancer
stage IIB prostate cancer
stage III prostate cancer
stage IV prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Motexafin gadolinium
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Dermatologic Agents

ClinicalTrials.gov processed this record on April 16, 2014