First in patients of a New PET Probe FEDAC

JRCT ID: jRCTs031220192

Registered date:07/07/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Malignant tumors(solid tumors)
• Date of first enrollment: 07/10/2022
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Positron emission tomography study using probe of [18F]FEDAC

Outcome(s)

Primary Outcome

The following points related to diagnostic performance will be evaluated and examined using PET/CT images of the region including the malignant tumor lesion of [18F]FEDAC.
# Ability to visualize malignant tumors
# Administered radioactivity
# Exploratory for the optimal conditions on PET imaging procedure

Secondary Outcome

1.If there is a clinical need and [18F]FDG PET/CT images are obtained, the ability to visualize malignant tumors with [18F]FDG and [18F]FEDAC will be compared.
2.Evaluation of adverse events

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 malignant tumors by histopathological examination performed within the past 90 days from the date of consent acquisition or by diagnostic imaging within the past 28 days from the date of consent acquisition
3.Subjects whose Performance Status (ECOG PS) is 0 or 1
4.Subjects who provide written informed consen

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 urine test) 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 is considered to be inappropriate to participate in this study by the investigator or co-investigator

Related Information

• Primary Sponsor: Tamura Kentaro