Those suspected of having a malignant tumor of bone after biopsy or CT or MRI examination
Conditions
Interventions
Index test:18F/89Zr-RANKL PET/CT imaging
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Subjects volunteered to participate in this trial and signed an informed consent form; 2) Age >=18 years and <=80 years (based on the date of signing the informed consent form), gender is not limited; 3) Female subjects of childbearing potential, male subjects, and partners of male subjects agree to use reliable contraception (e.g., abstinence, sterilization, birth control pills, injectable contraceptive megestrol, or subdermal contraception) for 6 months after the end of the final study drug infusion; 4) Patients with multiple myeloma and bone metastases from lung cancer, breast cancer, prostate cancer, etc. confirmed by puncture or surgical pathology; 5) Imaging findings of suspicious bone lesions; 6) Physical fitness score 0 to 1; 7) Expected survival time is more than 12 months; 8) Willingness and ability to comply with scheduled visits, diagnostic plans, clinical laboratory tests and other test procedures.
Exclusion criteria
Exclusion criteria: 1) Patients receiving antitumor therapy prior to PET/CT scan; 2) suffer from serious other neurological disorders, or gastrointestinal, cardiovascular, hepatic, renal, hematologic, respiratory, immunodeficiency, and other serious diseases; 3) Alternate subjects have conditions that contraindicate PET/CT scanning. including, but not limited to, elevated blood glucose that is not effectively controlled; pregnant, lactating, or breastfeeding women; those who are unable to receive repeated intravenous injections; those with possible allergies to the drug and its components (including a history of severe allergies or anaphylactic reactions, especially to the drug being examined); and agoraphobia; 4) Within the past year, have participated in other research protocols or clinical care, in addition to the radiation exposure expected from participation in this clinical study, which has resulted in radiation exposure in excess of an effective dose of 50 mSv; 5) Alternative subjects have undergone major surgery within the last 3 months; experimental drug or device therapy (of uncertain efficacy or safety) within 1 month; 6) The alternate subject has any clinical condition that, in the opinion of the Sponsor of this study, may cause or is potentially harmful by this agent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor SUV value; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity;specificity;accuracy; | — |
Countries
China
Contacts
Public ContactDong Mengjie
Peking University Shenzhen Hospital
Outcome results
None listed