MedPath

BB-PET

Phase 1
Recruiting
Conditions
Healthy subjects
Registration Number
JPRN-jRCTs041220159
Lead Sponsor
Kato Hiroki
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Male
Target Recruitment
20
Inclusion Criteria

The following criteria must be met by all subjects:
1) Male, in either of two age ranges: 20 to 30 years, or 65 to 80 years
2) Deemed healthy as determined by the physician investigators, based on a physical examination, medical history, vital signs and laboratory tests of blood and urine, and an electrocardiogram
3) Provision of a signed and dated informed consent to participate in the study

Exclusion Criteria

Subjects who have any of the following criteria will be excluded:
1) Having a malignant tumor, diabetes, or a serious renal, hepatic, cardiac or respiratory disease
2) History of renal, hepatic or cardiac (great arteritis) issues, or any related surgery
3) Receipt of iodinated contrast or MRI contrast agents within the previous month of enrolment
4) Determined by the physician investigators to be clinically unsuitable for the study, based on the screening visit and/or during the study procedures

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Evaluation of age-related standardized uptake value (SUV) of [18F]BCPP-BF in the kidneys, using Positron Emission Tomography/Computed Tomography (PET/CT)
Secondary Outcome Measures
NameTimeMethod
Evaluation of age-related standardized uptake value (SUV) of [18F]BCPP-BF in the liver and the heart (left ventricular myocardium) <br>Assessment of time-activity curves in major organ tissues (kidney, liver, left ventricular myocardium of the heart, etc.)
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