Changes in 18F-NaF PET/CT and 18F-FDG PET/CT after 223Ra Dichloride Treatment in Patients With Locally Recurrent of Metastatic Osteosarcoma
- Conditions
- Neoplasms
- Registration Number
- KCT0002905
- Lead Sponsor
- Korea Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
1. Patient with osteosarcoma with local recurrence or metastasis
- At least one recurrence or metastatic lesion confirmed with 18F-NaF PET/CT
- Patients with pulmonary metastases who are unable to treat with surgical resection.
- Patients with bone metastasis or local recurrence confirmed progressive disease after radiotherapy or chemotherapy
2. Able to provide informed consent and have signed an approved consent form that conforms to institutional guidelines to ensure compliance
3. Patients from 19 to 80 years of age
4. The Eastern Cooperative Oncology Group (ECOG) _ Performance scale =2
5. Those who satisfy the following conditions in blood test
- absolute neutrophil count (ANC)=1,500/µL
- Platelet count (PLT)=100,000/µL
- hemoglobin=10g/dL (100g/L; 6.2 mmol/L)
1. A person who is judged to be difficult to perform a clinical trial due to a serious medical condition
2. A person who is determined to have a mental disorder that is difficult to perform PET scan
3. Pre-menopausal women who are pregnant or breastfeeding during screening, or who plan to become pregnant during the test
4. Those participating in other clinical trials at screening and participating in clinical trials should be able to influence the acquisition of 18F-FDG or 18F-NaF 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-FDG or 18F-NaF PET images from the time of registration until the end of the study, or that may affect the safety assessment following intravenous injection of 223Ra dichloride
6. Those who are likely to influence the acquisition of 18F-FDG PET imaging due to unadjusted diabetes
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
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method standardized uptake value (SUV) of 18F-NaF PET;standardized uptake value (SUV) of 18F-FDG PET
- Secondary Outcome Measures
Name Time Method ALP (alkaline phosphatase);osteocalcin