Status:
UNKNOWN
Molecular PET/MR Imaging in Vivo Validation of Biomarker for Human Prostate Cancer
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Prostate Adenocarcinoma
Eligibility:
MALE
40-85 years
Brief 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 prosta...
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 th...
Eligibility Criteria
Inclusion
- Males
- 40-85 years of age
- Patients with a biopsy-proven or clinically highly suspected prostate adenocarcinoma, or benign prostatic hyperplasia
- Able to tolerate \[11C\]Choline PET scan and MRI scan
- Written informed consent from the patient
Exclusion
- Acute prostatitis or non-urologic bacterial infection requiring medical treatment within the last 3 months.
- History of AIDS in the period prior to the screening.3
- Contraindications to \[11C\]Choline PET/MR scans
- Surgical implants including pacemaker implants, cochlear implants, dentures held in place by magnets imbedded in the gums and aneurysm clips except those inserted at CGMH
- Metallic prosthesis of the hip or pelvic region
- Renal function impairment with estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m2
- Claustrophobia
- Medical drugs with choline
- Previous allergy to carbon-labeled radionuclide
- Active other malignancy within the last 2 years
- Subject which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety.
- Prisoners or patients with mental illness
Key Trial Info
Start Date :
January 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03451812
Start Date
January 1 2017
End Date
December 31 2019
Last Update
August 8 2019
Active Locations (1)
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1
Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital
Guishan, Taoyuan, Taiwan, 333