Development of Diagnostic Imaging of Pancreatic Cancer using New PET Probe

JRCT ID: jRCTs031210074

Registered date:10/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Pancreatic cancer
• Date of first enrollment: 20/07/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Positron emission tomography study using probe of [11C]MeLeu

Outcome(s)

Primary Outcome

Safety of [11C]MeLeu in human subjects
Radiation dosimetry of [11C]MeLeu in human subjects

• Secondary Outcome: Pharmacokinetics of [11C]MeLeu

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 is considered to be inappropriate to participate in this study.

Related Information

• Primary Sponsor: Yamazaki Kana