Tumor
Conditions
Brief summary
Exploring the therapeutic value of a novel dual target molecular probe NI-FAPI-04 PET/CT with hypoxia and fibroblast activation related proteins in fibroblast activation related tumors. This study will lay the foundation for the further application of NI-FAPI-04 in tumor therapy and achieve the integration of molecular targeted probes for diagnosis, treatment, and efficacy monitoring.
Interventions
DRUGInjection of 177Lu-NI-FAPI
Subjects were injected with 177Lu-NI-FAPI at 60mCi or 120mCi.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18-80 years old * Obtain pathological results through surgery or biopsy * Loss of surgical opportunity (distant metastasis, or unsuitability for surgery due to contraindications); The condition still progresses after conventional chemotherapy, radiotherapy, targeted drug therapy, and other treatments (according to RECIST/PERCAST criteria) * Expected survival time greater than 6 months * Baseline \[68Ga\] Ga-NI-FAPI-04 PET/CT imaging reveals high uptake lesions * Informed consent and the ability to accept follow-up * Bone marrow reserve: neutrophil count ≥ 1.5 × 109/L; platelet count ≥ 100 × 109/L; hemoglobin ≥ 90 g/L * Liver function: AST/ALT ≤ 3 × ULN, or subjects with liver metastasis\<5 × ULN; Albumin\>3.0 g/dL; Total bilirubin ≤ 1.5 × ULN * Renal function: creatinine clearance rate ≥ 50 mL/min * Coagulation function: INR ≤ 1.5 (for patients who have not received warfarin treatment); Prothrombin time (PTT)\<2 × ULN
Exclusion criteria
* Pregnant and lactating female patients * Individuals who fear confinement or radiation * Individuals who have received systemic anti-tumor treatment, including chemotherapy or curative radiotherapy, within 4 weeks prior to their first medication, or who have received TKI treatment within 2 weeks * Patients treated with isotopes such as strontium-89, samarium-153, rhenium 186, rhenium 188, radium-223, etc. within 6 months * Individuals who have experienced severe allergic reactions to the components of \[177Lu\] Lu-NI-FAPI-04 injection in the past * Received any investigational medication within 28 days prior to the first dose, or participated in another clinical study at the same time (except for those who participated in observational, non interventional clinical studies, or are currently in the follow-up period of interventional clinical studies) * Patients who are difficult to receive further diagnosis and treatment due to severe illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 6-8 weeks after administration | According to CTCAE v5.0, the number of patients who experienced adverse events was counted |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analysis of PET images before and after treatment | 6-8 weeks after administration | Describe the location of the lesion |
| The size of the lesion before and after treatment | 6-8 weeks after administration | Measure the size of the lesion（cm） |
| The degree of uptake of the lesion before and after treatment | 6-8 weeks after administration | Semi-quantitative analysis of changes in lesion uptake (SUVmax) before and after treatment |
Countries
China
Outcome results
None listed