Bone metastasis
Conditions
Interventions
None listed
Sponsors
The First Affiliated Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-80; 2. Patients with ECoG PS score of 0-2; 3. Patients with malignant tumor confirmed by pathology and suspected bone metastasis; 4. Patients who have not found bone metastasis and have not been treated with bisphosphonates or dinozumab; 5. Patients who have not received or received the pre-treatment (such as radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.) of acupuncture against tumor; 6. Patients with expected survival greater than 6 months; 7. Patients with good function of main organs, whose examination indexes meet the following requirements: blood routine examination: hemoglobin = 90 g / L (no blood transfusion within 14 days); neutrophil count = 1.5 × 109 / L; platelet count = 80 × 109 / L; biochemical examination: total bilirubin = 1.5 × ULN (upper limit of normal value); blood ALT or ast 2.5 × ULN; ALT or AST = 5 × ULN in case of liver metastasis; endogenous creatinine clearance = 50ml / min (Cockcroft Gault formula); 8. Patients willing to sign informed consent; 9. Patients with good compliance and family members agree to cooperate with them for survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients suffering from other malignant tumors at the same time, except for the cured or stable malignant tumors; 2. Pregnant or lactating women; 3. Patients who are unable to receive PET-CT, enhanced CT or MRI examination; 4. Patients with multiple factors affecting oral drugs (such as inability to swallow, chronic diarrhea, ulcerative colitis and intestinal obstruction, etc.); 5. In the 4 weeks before screening, patients who had any bleeding event with severe grade of 3 or more in ctcae4.0 were selected; 6. Before screening, patients with known or history of central nervous system metastasis; 7. Patients with hypertension who cannot be well controlled by single antihypertensive drug (systolic blood pressure > 140) MmHg, diastolic pressure > 90mmHg; patients with unstable angina history; patients newly diagnosed as angina within the first 3 months or with myocardial infarction within the first 6 months; patients with arrhythmia (including QTCF) requiring long-term use of antiarrhythmic drugs and grade II or above of New York Heart Association; 8. Patients with long-term unhealed wound or incomplete healing fracture; 9. Patients with previous organ transplantation history; 10. Patients whose imaging shows that the tumor has invaded the important blood vessels or who are highly likely to invade the important blood vessels during the treatment period and cause fatal bleeding according to the judgment of researchers; 11. Coagulation function was abnormal (PT > 16S, APTT > 43S, TT > 21s, FBG < 2G / L), patients with bleeding tendency (14 days before randomization, INR must be within the normal range without anticoagulant); patients treated with anticoagulant or vitamin K antagonists such as warfarin, heparin or their analogues; INR in prothrombin time Under the premise of 1.5, it is allowed to use low-dose warfarin (1 mg orally once a day) or low-dose aspirin (no more than 100 mg daily) for prevention purpose; 12. Patients who had the event of arteriovenous thrombus within one year before screening, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombus (except for the venous thrombus caused by venous catheterization due to pre chemotherapy, which is judged to be cured by the researchers), pulmonary embolism, etc; 13. Patients who have a history of psychoactive drug abuse and are unable to give up or have mental disorders; 14. Patients with a history of immune deficiency or other acquired or congenital immune deficiency diseases, or with a history of organ transplantation; 15. According to the judgment of the researchers, there are serious concomitant diseases that endanger the safety of the patients or affect the patients to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standardized Uptake Value;total metabolic tumor volume;total lesion glyclysis; | — |
Secondary
| Measure | Time frame |
|---|---|
| sensitivity;positive predicitive value;negative predicitive value; | — |
Contacts
Public ContactJing Liang
The First Affiliated Hospital of Shandong First Medical University
Outcome results
None listed