Clinical Trials List
Protocol NumberCPRPG3F0021-3
NCT Number(ClinicalTrials.gov Identfier)NCT03451812
2017-01-01 - 2019-12-31
Others
Recruiting1
ICD-10C61
Malignant neoplasm of prostate
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9185
Malignant neoplasm of prostate
Molecular PET/MR imaging in vivo validation of biomarker for human prostate cancer
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Trial Applicant
-
Sponsor
Chang Gung Memorial Hospital
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Trial scale
Taiwan Single Center
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Update
2025/08/20
Investigators and Locations
Linkou Chang Gung Medical Foundation
Chairman/Global PI
林吉晉
Co-Principal Investigator
- Jing-Ren Tseng Division of Nuclear Medicine
- 崔克宏 Division of Urology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Prostate Adenocarcinoma
Objectives
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.
Test Drug
[11C]Choline ([11C]Methyl-dimethyl-2-hydroxyethyl-ammonium), Glass vial with 40-331mCi of 11C choline in aqueous 0.9% sodium
Active Ingredient
[11C]Methyl-dimethyl-2-hydroxyethyl-ammonium
Dosage Form
injection
Dosage
40-331
Endpoints
Diagnostic Accuracy [ Time Frame: 1 year ]
sensitivity, specificity, accuracy
sensitivity, specificity, accuracy
Inclution Criteria
Inclusion Criteria:
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
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 Criteria
Exclusion Criteria:
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
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
The Estimated Number of Participants
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Taiwan
120 participants
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Global
0 participants
