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First in Human study of a New PET Probe FEDAC

Safety and pharmacokinetic study of a new PET probe [18F]FEDAC in healthy adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031210134
Enrollment
10
Registered
2021-06-08
Start date
2021-08-06
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

Malignant neoplasms

Interventions

Sponsors

Tamura Kentaro
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Healthy male subjects aged 20 or older and under 65 at the time of informed consent 2. Subjects who provide written informed consent 3. Subjects with BMI of less than 25

Exclusion criteria

Exclusion criteria: 1. Subjects who have severe or progressive complications. 2. Subjects who have obvious abnormalities in physical and laboratory examinations after obtaining the informed consent 3. Subjects who have past history of severe drug hypersensitivity 4. Subjects with drug or alcohol addiction 5. Subjects who smoke 6. Subjects who have received medication or used vitamins, herbal medicines, or supplements within 14 days prior to their visit 7. Subjects who are claustrophobic 8. Subjects who have undergone an examination with radiation exposure for the purpose of medical treatment (X-ray, CT, PET, DEXA, etc.) within the past 12 months, or for the purpose of research within the past 6 months. Chest X-rays conducted as part of the annual medical check are excluded. 9. Subjects who are considered to be inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
Safety of [18F]FEDAC in human subjects Radiation dosimetry of [18F]FEDAC in human subjects

Secondary

MeasureTime frame
Pharmacokinetics of [18F]FEDAC

Contacts

Public ContactKentaro Tamura

National Institutes for Quantum Science and Technology

tamura.kentaro@qst.go.jp+81-43-206-4076

Outcome results

None listed

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