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

JRCT ID: jRCTs041220041

Registered date:13/07/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Whole body search
• Date of first enrollment: 21/09/2022
• Target sample size: 11
• Study type: Interventional
• 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 Outcome: Safety associated with administration of [18F]BCPP-BF injection solution

Secondary Outcome

1) 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
• Gender: Both

Include criteria

1) 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 criteria

1) 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

• Primary Sponsor: Bunai Tomoyasu
• Secondary Sponsor: Harada Norihiro,Hamamatsu Photonics K.K.