Malignant bone metastases
Conditions
Interventions
therapeutic group:Subjects will receive 177Lu Phosphonate injection intravenously during treatment at an interval of 6±2 weeks, and the first cycle of treatment will be the DLT evaluation period, with
Imaging group:Only 68Ga/99mTc-phosphate imaging was performed in the development group
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1) Age =18 years old; 2) Patients with histologically proven bone diseases (primary or secondary bone tumors, fractures, bone tuberculosis and osteomyelitis); 3) Expected survival =6 months; 4) Blood routine, coagulation and liver and kidney function test results meet the following criteria: Blood routine: Hb> 80g/L, PLT> 75×109/L, WBC>3×109/L; PT or APTT=1.5ULN; Liver and kidney function: T-Bil=1.5×ULT (upper limit of normal value), ALT/AST=2.5ULN, ALP=4.5ULN; BUN=1.5×ULT, SCr=1.5×ULT; 5) Treatment screening: 68Ga-TBM imaging was positive before treatment (positive is usually a higher uptake of focal uptake imaging agent than normal bone); Subjects who agree to use contraception during the study period and for 6 months after the end of the study period; 6) Can understand and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) One of the following conditions exists, Brain metastases (other than metastatic brain tumors that are asymptomatic and do not require treatment), cancerous meningomyelitis, myocardial infarction (within the first 6 months of enrollment), unstable angina pectoris, or a high risk of uncontrollable arrhythmia, coronary bypass grafting, cerebrovascular accident (top 6 Within 1 month), congestive heart failure (grade ?-? of cardiac function), pulmonary embolism, deep vein thrombosis, infection requiring intravenous antibiotics within 2 weeks, immunosuppressive therapy after organ transplantation; 2) HBV DNA=104 copy number or =2000IU/ml; HCV-RNA=1000 copy number /ml; 3) HIV antibody or syphilis antibody positive; 4) History of acute or subacute intestinal obstruction, or inflammatory bowel disease; 5) Family planning within 6 months; 6) Allergic to any component of the investigational preparation; 7) Have a history of psychotropic drug abuse and can not quit or have mental disorders; 8) Can not lie flat for half an hour to receive PET/CT, SPECT/CT examination; 9) Other conditions deemed unsuitable for participation in the trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 99mTc-MDP SPECT/CTor 68Ga-TBM PET/CT imaging;Pain Degree; | — |
Countries
China
Contacts
Public ContactWang Xinlu
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed