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Modified-Release Drug Delivery Systems: Site-Targeted

Site-targeted drug delivery systems enhance therapeutic efficacy while minimizing systemic toxicity and treatment costs. Unlike conventional methods, these systems ensure precise drug delivery, improving bioavailability and reducing side effects. Targeted drug delivery is classified into three levels. First-order targeting directs drugs to the capillary beds of specific organs or tissues. Second-order targets specific cell types, such as tumor cells, using receptor-mediated interactions.
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Structure-Guided Designed [18F]-labeled FAPI for Enhanced Hydrophilicity: From Preclinical to First-In-Human Study.

Xingyu Mu1,2, Lei Zhang1,2, Zihao Chen3,4

  • 1Department of Nuclear Medicine, The First Affiliated Hospital of Guilin Medical University, Guilin 541001, China.

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Summary
This summary is machine-generated.

[18F]AlF-NOTA-GL01 is a novel PET imaging agent targeting fibroblast activation protein (FAP). It shows high tumor uptake, rapid clearance, and excellent contrast in preclinical and early human studies, supporting its clinical potential.

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Area of Science:

  • Nuclear Medicine
  • Radiochemistry
  • Oncology

Background:

  • Fibroblast activation protein (FAP) is highly expressed in cancer-associated fibroblasts.
  • FAP is an attractive target for positron emission tomography (PET) imaging in oncology.
  • Existing FAP-targeting agents may have limitations in terms of imaging characteristics or production.

Purpose of the Study:

  • To develop and evaluate [18F]AlF-NOTA-GL01, an improved FAP-targeting PET imaging agent.
  • To assess the radiochemical properties, binding affinity, and hydrophilicity of [18F]AlF-NOTA-GL01.
  • To evaluate the in vivo performance of [18F]AlF-NOTA-GL01 in preclinical models and a first-in-human study.

Main Methods:

  • Synthesis and radiolabeling of [18F]AlF-NOTA-GL01 using an Al[18F]-NOTA platform.
  • Determination of radiochemical purity, FAP binding affinity (IC50), and hydrophilicity (LogD).
  • PET imaging studies in A549-hFAP xenografts and a first-in-human study, including biodistribution and effective dose calculation. Comparison with [18F]FDG and [18F]FAPI-42.

Main Results:

  • [18F]AlF-NOTA-GL01 was obtained with high radiochemical purity (>95%) and high FAP binding affinity (IC50 = 2.94 nM).
  • Preclinical PET imaging demonstrated high tumor uptake (7.45 ± 2.34%ID/g at 60 min), rapid renal clearance, and low background.
  • The first-in-human study showed persistent tumor uptake to 120 min, favorable dosimetry (0.03 ± 0.01 mSv/MBq), and superior target-to-background ratios compared to [18F]FDG and [18F]FAPI-42.

Conclusions:

  • [18F]AlF-NOTA-GL01 is a promising FAP-targeting PET imaging agent with high affinity and excellent imaging properties.
  • The agent exhibits favorable pharmacokinetics, including rapid clearance and low background uptake.
  • The results support the clinical translation potential of [18F]AlF-NOTA-GL01 for improved cancer imaging.