First in Human study of a New PET Probe FEDAC

JRCT ID: jRCTs031210134

Registered date:08/06/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Malignant neoplasms
• Date of first enrollment: 06/08/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Positron emission tomography study using probe of [18F]FEDAC

Outcome(s)

Primary Outcome

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

• Secondary Outcome: Pharmacokinetics of [18F]FEDAC

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 65age old
• Gender: Male

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Tamura Kentaro