Efficacy and Safety of MeLeu in patients with pancreatic cancer

JRCT ID: jRCTs031220199

Registered date:08/07/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Pancreatic cancer
• Date of first enrollment: 06/09/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Positron emission tomography study using probe of [11C]MeLeu

Outcome(s)

Primary Outcome

The following points related to diagnostic performance will be evaluated and examined using PET/CT images including the pancreatic cancer lesion of [11C]MeLeu.
# Ability to visualize pancreatic cancer
# Administered radioactivity
# Exploratory for the optimal conditions on PET imaging procedure

Secondary Outcome

1.Comparison of PET/CT images of the abdomen including pancreatic cancer lesions of [18F] FDG and the ability to visualize pancreatic cancer
2.Evaluation of adverse events
3.Examination of association with SLC6A20, a blood transporter protein

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Subjects who are 18 years of age or older at the time of consent acquisition
2.Subjects who have been confirmed to have pancreatic cancer by histopathological or clinical examination
3.Subjects who have performed or are scheduled to perform [18F]FDG PET/CT by insurance within 30 days before or after the date of obtaining [11C]MeLeu PET/CT imaging, if [18F]FDG PET/CT imaging information is to be used
4.Subjects whose Performance Status (ECOG PS) is 0 or 1
5.Subjects who provide written informed consent

Exclude criteria

1.Subjects who have severe or progressive complications or subjects who have a history of these complications and are judged by the investigator or co-investigator to be unsuitable for this study
2.Subjects who have obvious abnormalities in physical and laboratory examinations (blood test and urinalysis) after obtaining the informed consent
3.Subjects with drug addiction or alcohol addiction
4.Subjects with mental illness or psychiatric symptoms who are judged to have difficulty in participating in this study
5.Subjects who are unable or restricted from the tests specified in the research plan
6.Subjects who are claustrophobic
7.Subjects who are considered to be inappropriate to participate in this study by the investigator or co-investigator

Related Information

• Primary Sponsor: Yamazaki Kana