Molecular PET/MR Imaging in Vivo Validation of Biomarker for Human Prostate Cancer (PCAPETMR)
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|ClinicalTrials.gov Identifier: NCT03451812|
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : March 29, 2018
To correlate the blood/urine metabolomic biomarkers with PET/MR imaging.
- To evaluate the sensitivity and specificity of the PET/MR in diagnosis of prostate cancer.
- To examine the diagnostic performance among subgroups of defined high-risk and low-risk subjects.
- To interrogate the metabolomic alterations with the molecular PET/MR to develop workable panel biomarkers.
|Condition or disease|
According to 2015 National Comprehensive Cancer Network (NCCN) guideline, medical imaging plays important roles for detection and staging for PCa, in addition to blood or urine biomarkers. Although there are a number of very different diagnostic imaging methods, e.g. transrectal ultrasound (TRUS), computed tomography (CT), magnetic resonance (MR) imaging and spectroscopy, or 18F-FDG positron emission tomography (PET), none of these have gained a dominant role as the optimum method for all clinical scenarios.The recently added armamentarium, PET/MR, might improve diagnosis in this regard.
Therefore, we conduct this trial to identify the ability of [11C]Choline PET/MR to evaluate the patients with prostate cancer, especially under the circumstance of elevated PSA level.
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Molecular PET/MR Imaging in Vivo Validation of Biomarker for Human Prostate Cancer|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
The newly diagnostic number for the high-risk PCa patients in our hospital annually is ~70, it is clinically feasible to recruit 40 patients a year since the study begins. The study could be completed in 3 years with 120 cases.
- Diagnostic Accuracy [ Time Frame: 1 year ]sensitivity, specificity, accuracy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451812
|Contact: Gigin Lin, MD, PhD||886-3281200 ext firstname.lastname@example.org|
|Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital||Recruiting|
|Guishan, Taoyuan, Taiwan, 333|
|Contact: Gigin Lin, MD, PhD 886-3281200 ext 2575 email@example.com|
|Principal Investigator:||Gigin Lin, MD, PhD||Medical Imaging and Intervention, Chang Gung Memorial Hospital|