Tumor bone metastases
Conditions
Interventions
Experimental group:68Ga/177Lu-TBM-001
Sponsors
Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years; 2. Patients with bone disease (primary or secondary bone tumor, fracture, bone tuberculosis and osteomyelitis) confirmed by histology; 3. Expected survival >=6 months; 4. The results of blood routine, coagulation and liver and kidney function test meet the following criteria: (1) Blood routine: Hb> 80g/L, PLT> 75x10^9/L, WBC>3x10^9/L; PT or APTT<=1.5ULN; (2) Liver and kidney function: T-Bil<=1.5xULT (upper limit of normal value), ALT/AST<=2.5ULN, ALP<=4.5ULN; BUN<=1.5xULT, SCr<=1.5xULT; 5. Before treatment, 68Ga-TBM-001 imaging was positive (positive usually means that the uptake of focal uptake imaging agent was higher than that of normal bone); Patients who agree to use contraception during the study period and for 6 months after the study period ends; 6. Can understand and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. The presence of any of the following conditions: brain metastases (other than metastatic brain tumors that are asymptomatic and do not require treatment), cancerous cerebrospinal meningitis, myocardial infarction (within the first 6 months of enrollment), unstable angina, or a high risk of uncontrolled arrhythmia, coronary artery bypass transplantation, cerebrovascular accident (within 6 months before enrollment), congestive heart failure (grade ?-? cardiac function), pulmonary embolism, deep vein thrombosis, infection requiring intravenous antibiotic treatment within 2 weeks, immunosuppressive therapy after organ transplantation; 2. HBV DNA>=10^4 copies or >=2000IU/ml; HCV-RNA>=1000 copy number /ml; 3. Hiv-positive or syphilis-positive; 4. Patients with a history of acute or subacute intestinal obstruction or inflammatory bowel disease; 5. Family planning within 6 months; 6. Allergic to any component of the study preparation; 7. Those who have a history of psychotropic substance abuse and cannot abstain or have mental disorders; 8. Can not lie flat for half an hour to receive PET/CT, SPECT/CT examination; 9. Situations in which other researchers found it inappropriate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum standardized uptake value;Overall survival;Progression-free survival; | — |
Countries
China
Contacts
Public ContactChen Yue
The Affiliated Hospital of Southwest Medical University
Outcome results
None listed