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

• ClinicalTrials.gov Identifier: NCT01562223
• Recruitment Status: Active, not recruiting
• First Posted: March 23, 2012
• Last Update Posted: August 25, 2020
• Sponsor: American College of Radiology Imaging Network
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): American College of Radiology Imaging Network

Tracking Information

• First Submitted Date: March 22, 2012
• First Posted Date: March 23, 2012
• Last Update Posted Date: August 25, 2020
• Actual Study Start Date: August 27, 2012
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 2, 2019)

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 ]

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

• Original Primary Outcome Measures (submitted: March 22, 2012): Repeatability assessment of DCE-MRI metrics Ktrans and blood-normalized initial area under the gadolinium curve (IAUGC90bn) and the DWI metric D(t)

Current Secondary Outcome Measures (submitted: July 2, 2019)

• 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 ]
  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 [ Time Frame: 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

Original Secondary Outcome Measures (submitted: March 22, 2012)

• Test-retest performance, assessed by the RC of Ktrans, IAUGC90bn, and D(t), and measured by median pixel values of the prostate tumor
• Reader effect on the RC of DCE-MRI and DWI metrics for whole prostate and tumor nodule target lesion
• Comparison between T1-dependent or T1-independent methods for gadolinium quantification produce differing values for the RC for Ktrans

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Studying Repeated DCE-MRI and DWI in Patients Diagnosed With Prostate Cancer
• Official Title: Repeatability Assessment of Quantitative DCE-MRI and DWI: A Multicenter Study of Functional Imaging Standardization in the Prostate

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.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Prostate Cancer

Intervention

Other: motexafin gadolinium

Other Name: Gadolinium

Study Arms

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.

Intervention: Other: motexafin gadolinium

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: March 22, 2012): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2021
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01562223
• Other Study ID Numbers: CDR0000728901; ACRIN-6701 ( Other Identifier: ACRIN Foundation ); U01CA080098 ( U.S. NIH Grant/Contract ); U01CA079778 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes

Plan Description

See ACRIN data Sharing Policy:

https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx

• Responsible Party: American College of Radiology Imaging Network
• Study Sponsor: American College of Radiology Imaging Network
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Mark A. Rosen; Abramson Cancer Center of the University of Pennsylvania

• PRS Account: American College of Radiology Imaging Network
• Verification Date: August 2020