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Safety evaluation of PET probe F18-NKO-035

Evaluation study of safety of cancer specific PET probe F18-NKO-035 for healthy male adults - NKO-PET study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs051190057
Enrollment
4
Registered
2019-10-08
Start date
2019-11-14
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

Normal healthy volunteer LAT1 PET diagnosis

Interventions

Sponsors

Watabe Tadashi
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) An adult male between 20 and 40 years of age 2) Person who is judged appropriate as a healthy person by a research principal doctor etc. after blood test, urine test and electrocardiogram test 3) Person who have obtained written consent for participation in this study from the applicant

Exclusion criteria

Exclusion criteria: 1) Person with past medical history less than 1 Malignant tumor, endocrine disease, heart failure, severe respiratory disease, liver dysfunction, renal dysfunction 2) Persons who have a history of severe hypersensitivity to components of PET drugs used in this study 3) Persons who have undergone computed tomography (CT), PET or cardiac catheterization within the past year 4) Persons who were judged inappropriate by the investigator as a subject

Design outcomes

Primary

MeasureTime frame
Estimation of whole body dose (effective dose) with F-18 NKO-035 administration (dose is similar to PET examination (4-8 mSv) using nuclide of same half life such as 18F-FDG-PET examination , Confirm that it does not exceed 10mSv.)

Secondary

MeasureTime frame
Adverse events and side effects Vital signs(systolic/diastolic blood pressure, pulse rate, respiratory rate, temperature) Electrocardiography Clinical examination( hematology, bold biochemistry, urinalysis)

Contacts

Public ContactTadashi Watabe

Osaka University Medical Hospital

watabe@tracer.med.osaka-u.ac.jp+81-6-6879-3461

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026