NCT03451812

Molecular PET/MR Imaging in Vivo Validation of Biomarker for Human Prostate Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: Male
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Primary objective: To correlate the blood/urine metabolomic biomarkers with PET/MR imaging. Secondary objectives: 1. To evaluate the sensitivity and specificity of the PET/MR in diagnosis of prostate cancer. 2. To examine the diagnostic performance among subgroups of defined high-risk and low-risk subjects. 3. To interrogate the metabolomic alterations with the molecular PET/MR to develop workable panel biomarkers.

Detailed description

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.

Conditions

• Prostate Adenocarcinoma

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2018-03-02
• Last updated: 2019-08-08

Locations

1 site across 1 country: Taiwan