JPRN-jRCT2032210711Active, not recruitingPhase 1
A Clinical Trial Investigating the Safety of 18F-PSMA-1007 Using a Synthetic Device for PET-Probe 18F-PSMA-1007 Targeting Prostate-Specific Membrane Antigen (PSMA) in Healthy Adults and Prostate Cancer Subjects.
Tateishi Ukihide0 sites13 target enrollmentStarted: March 31, 2022Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 13
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to < 80age old (—)
- Sex
- Male
Inclusion Criteria
- •Part A: Healthy adults
- •1, Japanese men aged 20 or older and under 65 at the time of consent acquisition
- •2, Individuals with a BMI of 18-28 kg/m2 at screening
- •Part B: Prostate cancer patients
- •1, Japanese men aged 20 or older and under 80 at the time of consent acquisition
- •2, Patients with histologically diagnosed prostate cancer
- •3, Those with a ECOG PS of 0-2
- •4, Patients with adequate organ function to participate in the clinical trial
Exclusion Criteria
- •Part A: Healthy adults
- •1, Individuals with a history of hypersensitivity to any drug or alcohol
- •2, Smokers and smokers who had smoked within 6 months of obtaining informed consent
- •3. Persons for whom ET/CT examination is contraindicated (persons with claustrophobia, etc.)
- •4, Individuals weighing more than 80 kg at screening or before administration
- •5. Individuals who are ill or have trauma that may affect pharmacokinetics
- •Part B: Prostate cancer patients
- •1.Persons with mental illness (including drug dependence, etc.) and severe renal failure, hepatic dysfunction, or other serious physical illness in the past and at the time of obtaining informed consent
- •2. Individuals with a history of alcohol hypersensitivity or alcohol dependence
- •3. Individuals with eGFR<60 at screen
- •4. Individuals for whom MRIs and PET/CT examinations are contraindicated (persons with metals in the body, persons with tattoos, etc., and persons with claustrophobia, etc.)
- •5. Those who have difficulty keeping the same entity for inspection time [about 30 minutes]
Investigators
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