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

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	Not Applicable

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 (Clinical Trial)
• Estimated 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: August 27, 2012
• Estimated Primary Completion Date: December 2020
• Estimated Study Completion Date: December 2021

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 Name: Gadolinium

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes 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

Locations

United States, Pennsylvania

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

American College of Radiology Imaging Network

National Cancer Institute (NCI)

Investigators

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

More Information

Additional Information:

National Cancer Institute's clinical trials database 

For more information about the ACRIN 6701 study, visit ACRIN.ORG. 

• Responsible Party: American College of Radiology Imaging Network
• ClinicalTrials.gov Identifier: NCT01562223
• Other Study ID Numbers: CDR0000728901; ACRIN-6701 ( Other Identifier: ACRIN Foundation ); U01CA080098 ( U.S. NIH Grant/Contract ); U01CA079778 ( U.S. NIH Grant/Contract )
• First Posted: March 23, 2012
• Last Update Posted: August 25, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Plan Description

See ACRIN data Sharing Policy:

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

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; Prostatic Diseases; Motexafin gadolinium; Antineoplastic Agents; Photosensitizing Agents; Dermatologic Agents