Status:
RECRUITING
68Ga-PSMA PET/MRI in Conjunction With mpMRI for Evaluating Prospective Prostate Cancer Risk
Lead Sponsor:
Chang Gung Memorial Hospital
Collaborating Sponsors:
National Science and Technology Council
Conditions:
Prostate Cancer
Eligibility:
MALE
40-85 years
Brief Summary
The goal of this observational study is to learn if Ga-68 PSMA PET/MRI can better diagnose prostate cancer than mpMRI in males between 40 to 85 years old who is naive to prostate biopsy and is suspici...
Eligibility Criteria
Inclusion Criteria:
- Patients who indicated MRI of pelvis due to clinical suspicion of prostate cancer based on elevated PSA (4~20 ng/mL), abnormal digital rectal examination or lower urinary tract syndromes.
- Males aged between 40 and 85 years with a life expectancy greater than two years.
- Naïve to prostate biopsy in the past.
- Assessment of daily physical status graded 0 to 2 based on the Eastern Cooperative Oncology Group (ECOG) criteria.
- Willing to sign the informed consent.
Exclusion Criteria:
- Unable to tolerate the PET/MRI scan, such as those with claustrophobia, unable to lie still, consciousness unclear, vital sign unstable, or having MRI unsafe metallic implants or devices.
- With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and allergy to medium contrast.
- High risk to conduct examination after evaluations of PI
- Patient had previous malignancy history
Key Trial Info
Start Date :
July 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT06494696
Start Date
July 1 2024
End Date
May 31 2027
Last Update
July 10 2024
Active Locations (1)
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1
Chang Gung Memorial Hospital ,Linkou
Taoyuan, Taiwan, 333