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

A study on the safety and utility of a novel mitochondrial function PET tracer [18F]BCPP-BF in healthy subjects: comparison with the first generation [18F]BCPP-EF

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041220041
Enrollment
11
Registered
2022-07-13
Start date
2022-09-21
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Whole body search

Interventions

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 distri

Sponsors

Bunai Tomoyasu
Lead Sponsor
Harada Norihiro
Collaborator
Hamamatsu Photonics K.K.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Safety associated with administration of [18F]BCPP-BF injection solution

Secondary

MeasureTime frame
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

Contacts

Public ContactTomoyasu Bunai

Hamamatsu University Hospital

bunai.t@hama-med.ac.jp+81-53-435-2515

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026