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

Prostate Cancer Clinical Trial

— A6701QIBA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01562223
• Other study ID #: CDR0000728901
• Secondary ID: ACRIN-6701U01CA0
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 27, 2012
• Est. completion date: December 2022

Study information

• Verified date: August 2021
• Source: American College of Radiology Imaging Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• motexafin gadolinium

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
American College of Radiology Imaging Network	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repeatability assessment of DCE-MRI metrics Ktrans and blood-normalized initial area under the gadolinium curve (IAUGC90bn) and the DWI metric D(t)	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	2 to 14 Days
Secondary	Test-retest performance, assessed by the RC of Ktrans, IAUGC90bn, and D(t), and measured by median pixel values of the prostate tumor	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 to 14 Days
Secondary	Comparison between T1-dependent or T1-independent methods for gadolinium quantification produce differing values for the RC for Ktrans	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	2 to 14 Days

External Links

•   For more information about the ACRIN 6701 study, visit ACRIN.ORG.
•   National Cancer Institute's clinical trials database