PET imaging of brain tumor using a 18F-FMT for tumor pharmacokinetics study: Microdose PET clinical trial
- Conditions
- Neoplasms
- Registration Number
- KCT0005042
- Lead Sponsor
- Korea Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 19
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.
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)
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics of 18F-FMT;Absorbed radiation doses per unit;Absorbed radiation doses per organ;Time dependent 18F-FMT uptake at the brain
- Secondary Outcome Measures
Name Time Method Time dependent 18F-FMT brain tumor/normal brain tissue uptake ratio