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Clinical Trial · NCT07822347
Research on NI-FAPI-04 for the Treatment of Hypoxic and Fibroblast Activation Protein Related Tumors
Overview
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.
Drug / Compound
NI-FAPI-04
Isotope(s):
LUTETIUM-177
Radioisotope: Lu-177
Theranostic Role: Therapeutic Agent & SPECT Imaging
T1/2 (Half-Life): 6.7 Days
Decay Mode: BETA, GAMMA
Energy: Eβeta max 497 keV, Gamma 113-208 keV
Range: In Tissue: 0.25-2mm
Decay Daughters: Hf177
Status: FDA Approvals: PLUVICTO® (2022), LUTATHERA® (2017)
Target(s):
- FAP
Ligand Class: Small Molecules
Chelator: DOTA
Eligibility
Inclusion
- Bone marrow reserve: neutrophil count ≥ 1.5 × 109/L; platelet count ≥ 100 × 109/L; hemoglobin ≥ 90 g/L
- Baseline \[68Ga\] Ga-NI-FAPI-04 PET/CT imaging reveals high uptake lesions
Exclusion
- Patients treated with isotopes such as strontium-89, samarium-153, rhenium 186, rhenium 188, radium-223, etc. within 6 months
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