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| ID | Type | Description | Link |
|---|---|---|---|
| ACRIN-6701 | Other Identifier | ACRIN Foundation | |
| U01CA080098 | U.S. NIH Grant/Contract | View source | |
| U01CA079778 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repeatability Assessment | Experimental | Gadolinium motexafin gadolinium All participants will undergo two consecutive DCE-MRI and DWI scans per same imaging parameters and subsequent comparison for repeatability. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| motexafin gadolinium | Other |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Comparison between T1-dependent or T1-independent methods for gadolinium quantification produce differing values for the RC for Ktrans |
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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:
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:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A. Rosen | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| Label | URL |
|---|---|
| National Cancer Institute's clinical trials database | View source |
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See ACRIN data Sharing Policy:
https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 5, 2023 | |
| Reset | Jul 25, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 5, 2023 | Jul 25, 2023 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C437683 | motexafin gadolinium |
| D005682 | Gadolinium |
| ID | Term |
|---|---|
| D028581 | Lanthanoid Series Elements |
| D008674 | Metals, Rare Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
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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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D008670 |
| Metals |