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First in patients of a New PET Probe FEDAC

Safety and pharmacokinetic study of a new PET probe [18F]FEDAC in patients with suspected malignant tumors

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031220192
Enrollment
30
Registered
2022-07-07
Start date
2022-10-07
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 tumors(solid tumors)

Interventions

Sponsors

Tamura Kentaro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

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