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

Primary Purpose

Prostate Cancer

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

motexafin gadolinium

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring stage IIA prostate cancer, stage IIB prostate cancer, stage III prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Repeatability Assessment

Arm Description

Gadolinium motexafin gadolinium All participants will undergo two consecutive DCE-MRI and DWI scans per same imaging parameters and subsequent comparison for repeatability.

Outcomes

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)

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

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

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

Full Information

NCT ID

NCT01562223

First Posted

March 22, 2012

Last Updated

October 15, 2021

Sponsor

American College of Radiology Imaging Network

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01562223

Brief Title

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

Acronym

A6701QIBA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 27, 2012 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

American College of Radiology Imaging Network

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

stage IIA prostate cancer, stage IIB prostate cancer, stage III prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Repeatability Assessment

Arm Type

Experimental

Arm Description

Gadolinium motexafin gadolinium All participants will undergo two consecutive DCE-MRI and DWI scans per same imaging parameters and subsequent comparison for repeatability.

Intervention Type

Other

Intervention Name(s)

motexafin gadolinium

Other Intervention Name(s)

Gadolinium

Primary Outcome Measure Information:

Title

Repeatability assessment of DCE-MRI metrics Ktrans and blood-normalized initial area under the gadolinium curve (IAUGC90bn) and the DWI metric D(t)

Description

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

Time Frame

2 to 14 Days

Secondary Outcome Measure Information:

Title

Test-retest performance, assessed by the RC of Ktrans, IAUGC90bn, and D(t), and measured by median pixel values of the prostate tumor

Description

The repeatability coefficient (RC) and its 95% confidence interval (CI) will be estimated for each metric using the method of Barnhart and Barboriak, 2009

Time Frame

2 to 14 Days

Title

Comparison between T1-dependent or T1-independent methods for gadolinium quantification produce differing values for the RC for Ktrans

Description

Time Frame

2 to 14 Days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark A. Rosen

Organizational Affiliation

Abramson Cancer Center at Penn Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital of the University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

See ACRIN data Sharing Policy: https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx

Links:

URL

https://clinicaltrials.gov/ct2/show/NCT01562223

Description

National Cancer Institute's clinical trials database

URL

http://www.acrin.org/6701_protocol.aspx

Description

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

Learn more about this trial

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

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