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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03451812 |
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Date of registration:
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26/02/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Molecular PET/MR Imaging in Vivo Validation of Biomarker for Human Prostate Cancer
PCAPETMR |
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Scientific title:
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Molecular PET/MR Imaging in Vivo Validation of Biomarker for Human Prostate Cancer |
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Date of first enrolment:
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January 1, 2017 |
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Target sample size:
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120 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03451812 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Gigin Lin, MD, PhD |
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Address:
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Telephone:
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886-3281200 |
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Email:
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giginlin@cgmh.org.tw |
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Affiliation:
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Name:
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Gigin Lin, MD, PhD |
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Address:
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Telephone:
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886-3281200 |
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Email:
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giginlin@cgmh.org.tw |
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Affiliation:
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Name:
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Gigin Lin, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical Imaging and Intervention, Chang Gung Memorial Hospital |
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Key inclusion & exclusion criteria
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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
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
1. 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
2. Metallic prosthesis of the hip or pelvic region
3. Renal function impairment with estimated glomerular filtration rate (eGFR) < 30
ml/min/1.73 m2
4. Claustrophobia
5. Medical drugs with choline
6. 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
Age minimum:
40 Years
Age maximum:
85 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Adenocarcinoma
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Primary Outcome(s)
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Diagnostic Accuracy
[Time Frame: 1 year]
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Secondary ID(s)
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104-4855A
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105-6435C
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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