Tokyo, May 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061430) titled 'Quantitative pharmacokinetic analysis of [18F]BCPP-EF in abdominal organs' on May 11.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Hamamatsu Medical Photonics Foundation
Condition:
Condition - Not applicable
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To estimate pharmacokinetic parameters related to MC-I binding of [18F]BCPP-EF in abdominal organs using compartment model analysis and to compare parametric images with semiquantitative tracer uptake images.
Basic objectives2 - Pharmacokinetics
Intervention:
Interventions/Control_1 - Blood sampling, intravenous PET tracer injection, CT imaging, and PET imaging
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - (1) Individuals who are => 20 years old and < 70 years old at the time of informed consent acquisition
(2) Individuals without a psychiatric or neurological history
(3) Individuals without a smoking history
(4) Individuals without alcoholics
(5) Individuals not taking regular medicines
(6) Capability of written informed consent based on their own decision
Key exclusion criteria - (1) Healthy subjects who have participated in another nuclear medicine study within the past year.
(2) Pregnant, possibly pregnant or lactating women
(3) Others judged inappropriate for the study by the investigator(s).
Target Size - 6
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 18 Day
Anticipated trial start date - 2026 Year 07 Month 01 Day
Last follow-up date - 2028 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070182
Disclaimer: Curated by HT Syndication.
