Tumor
Conditions
Interventions
68Ga-DOTA-BT1718 Imaging Group:68Ga-DOTA-BT1718 Injection, single dose, intravenous administration, dose 5mCi
18F-DOTA-BT1718 Imaging Group:18F-DOTA-BT1718 Injection, single dose, intravenous administration, dose 5mCi
177Lu-DOTA-BT1718 Therapy Group:177Lu-DOTA-BT1718 Injection, single dose, intravenous administration, dose 133.15~199.42mCi
Sponsors
Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The age should be between 18 and 70 years old (both 18 and 70 years old are included), regardless of gender. 2. Patients with solid tumors who have undergone pathological tissue biopsy or received surgical treatment for tumors (including head and neck cancer, pancreatic cancer, glioma, fibrosarcoma, etc.). 3. ECOG score is 0-1 point. 4. The expected survival time is >= 12 weeks. 5. The results of blood routine, coagulation, and liver and kidney function tests meet the following criteria: For blood routine: WBC >=4.0×10^9/L or neutrophils >=1.5×10^9/L, PLT >= 100×10^9/L, Hb >=90g/L; PT or APTT <= 1.5 ULN; For liver and kidney functions: T-Bil <= 1.5×ULT (upper limit of normal value), ALT/AST <= 2.5 ULN or <= 5×ULT (for subjects with liver metastases), ALP <= 2.5 ULN (if there are bone metastases or liver metastases, ALP <= 4.5 ULN); BUN <= 1.5×ULT, SCr <= 1.5×ULT. 6. According to the RECIST 1.1 standard, there should be at least one measurable target lesion in solid tumors. 7. Female subjects must adopt effective contraceptive measures during the study period and within 6 months after the end of the study (effective contraceptive measures refer to sterilization, intrauterine hormonal devices, condoms, contraceptive pills/agents, abstinence, or vasectomy of the partner, etc.). Male subjects should agree to adopt contraceptive measures during the study period and within 6 months after the end of the study. 8. Those who can understand and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Any of the following conditions exist: brain metastasis (except for asymptomatic primary or metastatic brain tumors that do not require treatment), carcinomatous meningitis, myocardial infarction (within 6 months before enrollment), unstable angina pectoris, or a high risk of uncontrollable arrhythmia, coronary artery bypass grafting, cerebrovascular accident (within 6 months before enrollment), congestive heart failure (cardiac function class III-IV), pulmonary embolism, deep vein thrombosis, infection that requires intravenous antibiotic treatment within 2 weeks, and treatment with immunosuppressive agents after organ transplantation. 2. Primary central nervous system tumors. 3. HBV DNA >=10^4 copies or >=2000 IU/ml. 4. HCV-RNA >=1000 copies/ml. 5. Positive for human immunodeficiency virus antibody or syphilis antibody. 6. History of acute or subacute intestinal obstruction, or inflammatory bowel disease. 7. Females who are pregnant, lactating, or planning to become pregnant. 8. Those who are known to be allergic to the study preparation or its excipients. 9. Those with a history of mental drug abuse who are unable to quit or have a mental disorder. 10. Those who cannot lie flat for half an hour. 11. Those who are allergic to any component of the imaging agent or antibody. 12. Those who cannot undergo PET/CT imaging. 13. Other situations that the researcher deems unsuitable for participating in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The standardized uptake value (SUV) of the tumor lesion of interest.;The ratio of the standardized uptake value (SUV) of the tumor lesion or suspected tumor lesion of interest to the standardized uptake value of the normal tissue corresponding to the tumor lesion or suspected tumor lesion (SUVR).;The radiation doses to the whole body and each major tissue/organ of the subjects after drug administration.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters:T1/2CLCmaxAUCdL;;The optimal imaging time;The adverse events and their incidence rates in the clinical application of imaging agents.; | — |
Countries
China
Contacts
Public ContactQiu Lin
Affiliated Hospital of Southwest Medical University
Outcome results
None listed