NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041220041

Registered date:13/07/2022

A study on the safety and utility of a novel Mitochondrial Function PET tracer [18F]BCPP-BF

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedWhole body search
Date of first enrollment21/09/2022
Target sample size11
Countries of recruitment
Study typeInterventional
Intervention(s)To evaluate the safety associated with the administration of [18F]BCPP-BF injection solution in healthy subjects and to estimate the radiation dose. In addition, we will evaluate changes in the distribution of [18F]BCPP-BF and [18F]BCPP-EF throughout the body, including the brain.

Outcome(s)

Primary OutcomeSafety associated with administration of [18F]BCPP-BF injection solution
Secondary Outcome1) Estimated radiation dose associated with administration of [18F]BCPP-BF injection solution 2) Comparison of the whole-body distribution of [18F]BCPP-BF and [18F]BCPP-EF 3) MRI Examination: Evaluation of T1 structural MRI

Key inclusion & exclusion criteria

Age minimum>= 40age old
Age maximum<= 80age old
GenderBoth
Include criteria1) Between 40 and 80 years of age 2) Healthy individuals with no history or current medical history 3) Persons whose consent to participate in this study has been obtained by signing a consent form in person
Exclude criteria1) Those who need to take medication (whether on a regular or occasional basis) 2) Women who are pregnant or may become pregnant 3) Women who are breastfeeding 4) Patients with claustrophobia 5) Those with contraindications to MRI (pacemakers, metals in the body, tattoos, etc.) 6) Those who have participated in other studies using nuclear medicine examinations within one year of obtaining consent 7) Other subjects who are deemed inappropriate as research subjects by the principal Investigator or research supervisor

Related Information

Contact

Public contact
Name Tomoyasu Bunai
Address 1-20-1,Handayama,Chuo-ku,Hamamatsu,Shizuoka Shizuoka Japan 431-3192
Telephone +81-53-435-2515
E-mail bunai.t@hama-med.ac.jp
Affiliation Hamamatsu University Hospital
Scientific contact
Name Tomoyasu Bunai
Address 1-20-1,Handayama,Chuo-ku,Hamamatsu,Shizuoka Shizuoka Japan 431-3192
Telephone +81-53-435-2515
E-mail bunai.t@hama-med.ac.jp
Affiliation Hamamatsu University Hospital