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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Contrast Media
Diagnostic Uses of Chemicals
Photosensitizing Agents
Dermatologic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 18, 2014