Prostate Cancer Localization With a Multiparametric Magnetic Resonance (MR) Approach
Status: | Active, not recruiting |
---|---|
Conditions: | Prostate Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 4/21/2016 |
Start Date: | June 2010 |
End Date: | December 2016 |
Prostate Cancer Localization With a Multiparametric MR Approach
The primary objective of this prospective multi-centre study is to prove the diagnostic
accuracy of in vivo 3T multi-modality Magnetic Resonance Imaging (high resolution
T2-weighted MRI, DCE-MRI, MRSI and DWI techniques) in distinguishing carcinoma from other
prostate tissue. The gold standard for distinguishing the tissue types is the analysis of
whole-mount sections of the resected prostate by a genitourinary histopathologist.
accuracy of in vivo 3T multi-modality Magnetic Resonance Imaging (high resolution
T2-weighted MRI, DCE-MRI, MRSI and DWI techniques) in distinguishing carcinoma from other
prostate tissue. The gold standard for distinguishing the tissue types is the analysis of
whole-mount sections of the resected prostate by a genitourinary histopathologist.
Goal Proving that multi-parametric MR imaging in a multi-centre setting allows for
localizing clinically significant (volume > 0.5cc; Gleason > 6) prostate carcinoma in the
prostate.
Objective 1
To determine the diagnostic accuracy (area under the receiver-operating characteristic
curve) of 3-Tesla multi-modality non-endorectal coil (ERC) MR imaging in localizing prostate
cancer, by correlating:
1. focal areas of low signal intensity on T2-weighted images;
2. the extent and degree of deviating metabolite ratios derived from MRSI. This can be the
choline+creatine/citrate ratio or if possible, the choline / citrate ratio;
3. the extent and degree of apparent diffusion coefficient reduction on DWI;
4. the extent and degree of perfusion abnormality on DCE-MRI; with the presence or absence
of cancer at (reconstructed) whole mount section histopathology.
Objective 2 Proving that multi-modality MR data allows for predicting tumor grade. The
parameters from the different MR methods for a tumor focus can be correlated to the local
Gleason grade of the corresponding lesion in the histopathological specimens.
localizing clinically significant (volume > 0.5cc; Gleason > 6) prostate carcinoma in the
prostate.
Objective 1
To determine the diagnostic accuracy (area under the receiver-operating characteristic
curve) of 3-Tesla multi-modality non-endorectal coil (ERC) MR imaging in localizing prostate
cancer, by correlating:
1. focal areas of low signal intensity on T2-weighted images;
2. the extent and degree of deviating metabolite ratios derived from MRSI. This can be the
choline+creatine/citrate ratio or if possible, the choline / citrate ratio;
3. the extent and degree of apparent diffusion coefficient reduction on DWI;
4. the extent and degree of perfusion abnormality on DCE-MRI; with the presence or absence
of cancer at (reconstructed) whole mount section histopathology.
Objective 2 Proving that multi-modality MR data allows for predicting tumor grade. The
parameters from the different MR methods for a tumor focus can be correlated to the local
Gleason grade of the corresponding lesion in the histopathological specimens.
Inclusion Criteria:
- Biopsy-proven diagnosis of adenocarcinoma of the prostate
- Subject will sign a consent form prior to study entry
- Radical prostatectomy and histopathological exam planned
- The time interval between last biopsy and the MR exam must be at least 4 weeks
- The time interval between MR exam and radical prostatectomy should not exceed 12
weeks
Exclusion Criteria:
- Subjects who are unable to give valid informed consent
- Subjects who are unwilling or unable to undergo an MR exam, including subjects with
contra-indications to MR exams
- Therapy or surgical procedure applied to the prostate or to other organs in vicinity
to the prostate: among the therapies preventing inclusion are any form of radiation
therapy, cryo-therapy, thermal-therapy, therapy based on any other medication
(including hormonal therapy).
- Patients under hormone deprivation therapy.
We found this trial at
3
sites
10833 Le Conte Ave
Los Angeles, California 90095
Los Angeles, California 90095
(310) 825-4321
David Geffen School of Medicine, UCLA In 2002 Mr. David Geffen announced a $200 million...
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