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PET imaging of brain tumor using a 18F-FMT for tumor pharmacokinetics study: Microdose PET clinical trial

PET imaging of brain tumor using a 18F-FMT for tumor pharmacokinetics study: Microdose PET clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0005042
Enrollment
19
Registered
2020-05-20
Start date
2016-05-17
Completion date
Unknown
Last updated
2020-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Korea Cancer Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with a brain tumor 1. Patients with a primary or metastatic brain tumor with more-than-1.0 cm-diameter detected by MRI, CT, or F-18 FDG PET/CT scan 2. More than 3 weeks after the last chemotherapy or radiotherapy 3. Age = 18 years 4. The patient is capable of giving informed consent, complying with the restrictions and requirements of the protocol 5. In case of women in childbearing age, medically reliable contraception will be agreed. Control subjects 1. No history of a brain tumor or other malignancy 2. Age = 18 years 3. The patient is capable of giving informed consent, complying with the restrictions and requirements of the protocol. 4. In case of women in childbearing age, medically reliable contraception will be agreed.

Exclusion criteria

Exclusion criteria: 1. Those who were judged as difficult to conduct the clinical trial due to serious medical conditions by the investigator. 2. Those who were judged to have a mental illness that makes it difficult to obtain positron emission tomography (PET) by the investigator. 3. Pre-menopausal women who are pregnant, lactating, or planning a pregnancy during the clinical trial period. 4. Those participating in other clinical trials at screening and participating in clinical trials should be able to influence the acquisition of 18F-FMT PET images (For example, if you are participating in another cohort-based trial that is simply focused on monitoring that you do not receive medicines during screening, you can participate in the current clinical trials). 5. Those who participated in other clinical trials that may affect the acquisition of 18F-FMT PET images from the time of registration until the end of the study, or that may affect the safety assessment following intravenous injection of 18F-FMT (For example, if you are participating in another cohort-based trial that is simply focused on monitoring that you do not receive medicines during screening, you can participate in the current clinical trials). 6. Those who satisfy the following conditions in blood test - absolute neutrophil count (ANC) < 1,000/µL - hemoglobin < 8g/dL - Platelet count (PLT) < 50,000/µL - Serum creatinine > 3.0 x upper limit of normal (ULN) - AST, ALT > 5.0 x upper limit of normal (ULN) 7. Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation. 8. Vulnerable subjects (researchers or students who participated in research, family members, researchers or students of researchers participating in research)

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics of 18F-FMT;Absorbed radiation doses per unit;Absorbed radiation doses per organ;Time dependent 18F-FMT uptake at the brain

Secondary

MeasureTime frame
Time dependent 18F-FMT brain tumor/normal brain tissue uptake ratio

Countries

Korea, Republic of

Contacts

Public ContactHansol Moon

Korea Cancer Center Hospital

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026