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Preclinical study and first-in-human imaging of [¹⁸F]FAP-2286, and comparison with 2-[¹⁸F]FDG PET/CT in various

Lifang Liu^1,2, Jiawei Zhong³, Ziqi Zhang³

¹Nuclear Medicine Department, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510120, China.

European Journal of Nuclear Medicine and Molecular Imaging

|February 7, 2024

View abstract on PubMed

Summary

A novel tracer, [18F]FAP-2286, demonstrates high specificity and uptake for fibroblast-activated protein (FAP) in preclinical and clinical cancer imaging. This FAP-targeting agent shows promise as an alternative to 2-[18F]FDG PET for certain non-avid cancers.

Keywords:

Al18F-PET/CT Clinical conversion FAP-2286 Fibroblast activation protein-α

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Area of Science:

Radiochemistry and Nuclear Medicine
Oncology
Molecular Imaging

Background:

Fibroblast-activated protein (FAP) is a transmembrane protease highly expressed on cancer-associated fibroblasts (CAFs) in many solid tumors.
FAP expression is significantly lower or absent in normal tissues, making it an attractive target for cancer imaging and therapy.
Current imaging agents have limitations, necessitating the development of novel, high-performance tracers.

Purpose of the Study:

To develop and characterize a novel FAP-specific positron emission tomography (PET) tracer, [18F]FAP-2286.
To evaluate the preclinical performance of [18F]FAP-2286 in comparison to existing agents like [18F]FAPI-42 and [68Ga]Ga-FAP-2286.
To assess the clinical utility of [18F]FAP-2286 in patients with various cancers, comparing it with 2-[18F]FDG PET.

Main Methods:

[18F]FAP-2286 was synthesized under Good Manufacturing Practice (GMP) conditions.
In vitro assays included cell uptake, competitive binding affinity, internalization, and efflux studies using HT-1080hFAP cells.
In vivo studies involved PET imaging and biodistribution in tumor-bearing mice models and a pilot clinical study in 15 cancer patients.

Main Results:

[18F]FAP-2286 achieved a radiolabeling yield of 30.53 ± 5.20% with >97% radiochemical purity.
In vitro, the tracer exhibited specific uptake, high internalization, and low efflux.
PET imaging revealed rapid tumor uptake and satisfactory retention in both preclinical models and cancer patients.

Conclusions:

[18F]FAP-2286 demonstrates superior imaging characteristics, including rapid and high target uptake and sustained retention.
The tracer shows potential as an effective tool for early or delayed phase PET imaging.
[18F]FAP-2286 may serve as a valuable alternative for imaging cancers that are non-avid to 2-[18F]FDG, particularly those with low glucose metabolism.