Studying Repeated DCE-MRI and DWI in Patients Diagnosed With Prostate Cancer (A6701 QIBA)
This study is currently recruiting participants.
Verified January 2013 by American College of Radiology Imaging Network
Sponsor:
American College of Radiology Imaging Network
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
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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
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 Photosensitizing Agents Radiation-Sensitizing Agents Physiological Effects of Drugs Dermatologic Agents |
ClinicalTrials.gov processed this record on May 21, 2013