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 enrollmentMarch 31, 2022

Overview

No summary available.

Registry

who.int

Start Date

March 31, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

Male

Sponsor

Tateishi Ukihide

•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

•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