BB-PET

JRCT ID: jRCTs041220159

Registered date:13/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy subjects
• Date of first enrollment: 04/10/2023
• Target sample size: 20
• Study type: Interventional

Intervention(s)

This study is
1) to investigate the standardized uptake value (SUV) of normal organs in healthy adult men (ages 20-30 years) and older adult men (ages 65-80 years), and also 2) to evaluate the efficacy and safety of injected [18F]BCPP-BF as a radiopharmaceutical.

Subjects are each to receive a single intravenous injection of the [18F]BCPP-BF tracer (3.7MBq/kg, using a minimum dose of 111MBq up to a maximum of 370 MBq) and undergo a whole-body Positron Emission Tomography/Computed Tomography (PET/CT) scan. Images are to be obtained from the vertex to the upper thigh region. CT scan is to be performed over the same region for attenuation correction in PET images and to obtain fusion images.

- Three subjects within the adult group of ages 20-30 are to undergo a 90-minute PET/CT scan, immediately following an intravenous injection of the [18F]BCPP-BF tracer. These three subjects will be randomly selected by the physician investigators as being suitable for a 90-minute PET/CT scan.

- Seven subjects within the adult group of ages 20-30 are to undergo a 20-minute PET/CT scan, 60-minutes following an intravenous injection of the [18F]BCPP-BF tracer.

- Ten subjects within the older adult group of ages 65-80 are to undergo a 20-minute PET/CT scan, 60-minutes following an intravenous injection of the [18F]BCPP-BF tracer.

Outcome(s)

• Primary Outcome: 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

Evaluation of age-related standardized uptake value (SUV) of [18F]BCPP-BF in the liver and the heart (left ventricular myocardium)
Assessment of time-activity curves in major organ tissues (kidney, liver, left ventricular myocardium of the heart, etc.)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Male

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kato Hiroki
• Secondary Sponsor: Harada Norihiro,Hamamatsu Photonics K.K.