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Clinical Trial · NCT07144085
Application of ⁶⁸Ga-FXX489 (NNS309) PET/CT Imaging in Diagnosis of Tumor Diseases.
Overview
A new radiotracer, 68Ga-FXX489 (NNS309), has been developed for tracking fibroblast activation protein (FAP) and visualizing the tumor stroma. The purpose of the study is to explore the diagnostic value of 68Ga-FXX489 (NNS309) PET/CT imaging in oncological diseases, to assess its safety, imaging characteristics, and biodistribution after administration.
Sponsor
First Hospital of China Medical University
Phase
Phase 1
Contacts
Xuena Li (STUDY_DIRECTOR)
Xuena Li (CONTACT)
lixuenacmunm@163.com
0086-18040099351
ClinicalTrials.gov
NCT07144085Drug / Compound
FXX489
Isotope(s):
GALLIUM-68
Radioisotope: Ga-68
Theranostic Role: PET Imaging
T1/2 (Half-Life): 68 minutes
Decay Mode: POSITRON β+ (88.9%), GAMMA, ELECTRON CAPTURE (8.7%)
Energy: Beta: max 1.9 MeV Gamma 1.1 MeV, 511 keV
Range: N/A
Decay Daughters: Zn68 (Stable)
Status: FDA Approvals: NETSPOT® (2016), LOCAMETZ® (2022), ILLUCIX® (2021)
Target(s):
- FAP
Ligand Class: Peptides
Chelator: DOTA
FAP-2286
Isotope(s):
GALLIUM-68
Radioisotope: Ga-68
Theranostic Role: PET Imaging
T1/2 (Half-Life): 68 minutes
Decay Mode: POSITRON β+ (88.9%), GAMMA, ELECTRON CAPTURE (8.7%)
Energy: Beta: max 1.9 MeV Gamma 1.1 MeV, 511 keV
Range: N/A
Decay Daughters: Zn68 (Stable)
Status: FDA Approvals: NETSPOT® (2016), LOCAMETZ® (2022), ILLUCIX® (2021)
Target(s):
- FAP
Ligand Class: Peptides
Chelator: DOTA
Eligibility
Inclusion
- Patients with a high suspicion of oncological diseases.
Exclusion
- Severe cardiac dysfunction, cardiac function class III-IV.
- Renal failure (serum creatinine level \> 1.2 mg/dl).
- Severe visual or auditory impairment, cognitive disorders, or patients with claustrophobia who cannot communicate effectively.
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