Solid tumors
Conditions
Interventions
Cohort 2: The results of imaging follow-up, pathological puncture, and comprehensive analysis based on the subject's medical records
Index test:68Ga-JJH0527 PET/CT
18F-FDG PET/CT.
Sponsors
Affiliated Hospital of North Sichuan Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Prior to participating in the study, a signed informed consent form must be obtained; 2. Aged >= 18 years, male or female patients; 3. Histologically or cytologically confirmed digestive tumors (gastric cancer, pancreatic cancer, esophageal cancer, gallbladder/bile duct cancer are preferred), head and neck squamous cell carcinoma, or peritoneal metastases; 4. Cohort 1: Patients with operable or borderline operable resection, scheduled for primary lesion resection and peripheral lymph node dissection, and suspected presence of peripheral lymph node or distant metastasis; The pathological results of the primary lesion and lymph node dissection were obtained; Cohort 2: Patients with confirmed or suspected postoperative recurrence or advanced metastasis by routine imaging had at least one measurable lesion (with a short diameter = 1.5cm for lymph node lesions and a long diameter = 1cm for non lymph node lesions); Patients who can undergo imaging follow-up for 3 to 6 months or can undergo pathological biopsy; 5. The ECOG score is 0-2; 6. Patients with adequate organ function: Bone marrow reserve: neutrophil count (ANC) = 1.5 × 10 ^ 9/L, platelet count = 100 × 10 ^ 9/L, hemoglobin = 90g/L; Liver: total bilirubin (TBIL) = 1.5 times the upper limit of normal value (ULN) (= 3 times the upper limit of normal value (ULN) is applicable to patients with bile duct cancer, gallbladder cancer, and pancreatic cancer), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3.0 × ULN; Kidney: Blood creatinine (SCr) = 1.5 × ULN.
Exclusion criteria
Exclusion criteria: 1. Previously received FAP-targeted radioligand therapy; 2. Patients are participating in any other clinical trials or receiving investigational drugs; 3. Patients who plan to receive anti-tumor treatment between two scans, including but not limited to chemotherapy, radiotherapy, immunotherapy, etc; 4.Patients with central nervous system (CNS) metastases with symptoms or receiving glucocorticoid therapy to maintain functional integrity of the nervous system; 5. Merge active autoimmune diseases, including but not limited to inflammatory bowel disease, etc; 6. Patients who are allergic to research drugs or known ingredients; 7. Patients with other malignancies that may interfere with disease assessment, who have a prior history of malignancy but have been adequately treated, who have not been treated for more than 3 years prior to enrollment, and who have no evidence of recurrence are eligible to participate in the study; 8. Comorbidities with serious or poorly controlled medical conditions, including but not limited to hard-to-control infections (including severe or poorly recovered COVID-19 infections), known active hepatitis B or C, or other conditions that investigators believe may impair study participation or collaboration; 9. A physical or psychiatric history that may interfere with the purpose and evaluation of the study, or any condition in which the investigator determines that the patient is incapable of cooperating with imaging and procedures; 10. Patients who do not consent to effective contraception or restricted sexual practices; 11. There are other conditions that the investigator deems unsuitable for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity;Positive prediction rate;Negative prediction rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Biological distribution characteristics;Safety; | — |
Countries
China
Contacts
Public ContactChen Fei
Affiliated Hospital of North Sichuan Medical College
Outcome results
None listed