Izquierdo-Garcia David, Désogère Pauline, Philip Anne L, Sosnovik David E, Catana Ciprian, Caravan Peter
Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, 149 Thirteen St. Suite 2301, Boston, MA, 02129, USA.
Harvard Medical School, Boston, MA, USA.
Mol Imaging Biol. 2025 Feb;27(1):99-108. doi: 10.1007/s11307-024-01973-3. Epub 2024 Dec 4.
This study presents for the first time in humans the biodistribution, clearance and dosimetry estimates of [Cu]Fibrin Binding Probe #8 ([Cu]FBP8) in healthy subjects. [Cu]FBP8-PET previously demonstrated its potential in two recent applications: thrombus imaging and pulmonary fibrosis.
This prospective study included 8 healthy subjects to evaluate biodistribution, safety and dosimetry estimates of [Cu]FBP8, a fibrin-binding positron emission tomography (PET) probe. All subjects underwent up to 3 sessions of PET/Magnetic Resonance Imaging (PET/MRI) 0-2 h, 4 h and 24 h post injection. Dosimetry estimates were obtained using OLINDA 2.2 software.
Subjects were injected with 400 MBq of [Cu]FBP8. Subjects did not experience adverse effects due to the injection of the probe. [Cu]FBP8 PET images demonstrated fast blood clearance (half-life = 67 min) and renal excretion of the probe, showing low background signal across the body. The organs with the higher doses were: the urinary bladder (0.075 vs. 0.091 mGy/MBq for males and females, respectively); the kidneys (0.050 vs. 0.056 mGy/MBq respectively); and the liver (0.027 vs. 0.035 mGy/MBq respectively). The combined mean effective dose for males and females was 0.016 ± 0.0029 mSv/MBq, lower than the widely used [F]fluorodeoxyglucose ([F]FDG, 0.020mSv/MBq).
This study demonstrates the following properties of the [Cu]FBP8 probe: low dosimetry estimates; fast blood clearance and renal excretion; low background signal; and whole-body acquisition within 20 min in a single session. These properties provide the basis for [Cu]FBP8 to be an excellent candidate for whole-body non-invasive imaging of fibrin, an important driver/feature in many cardiovascular, oncological and neurological conditions.
本研究首次在人体中展示了[铜]纤维蛋白结合探针#8（[Cu]FBP8）在健康受试者体内的生物分布、清除情况及剂量学估计。[Cu]FBP8正电子发射断层扫描（PET）先前在两项近期应用中展现了其潜力：血栓成像和肺纤维化。
这项前瞻性研究纳入了8名健康受试者，以评估纤维蛋白结合正电子发射断层扫描（PET）探针[Cu]FBP8的生物分布、安全性及剂量学估计。所有受试者在注射后0 - 2小时、4小时和24小时接受了多达3次PET/磁共振成像（PET/MRI）检查。使用OLINDA 2.2软件获得剂量学估计值。
受试者注射了400MBq的[Cu]FBP8。受试者未因注射该探针而出现不良反应。[Cu]FBP8 PET图像显示该探针血液清除迅速（半衰期 = 67分钟）且经肾脏排泄，全身背景信号较低。接受较高剂量的器官分别为：膀胱（男性和女性分别为0.075与0.091mGy/MBq）；肾脏（分别为0.050与0.056mGy/MBq）；以及肝脏（分别为0.027与0.035mGy/MBq）。男性和女性的合并平均有效剂量为0.016±0.0029mSv/MBq，低于广泛使用的[氟]氟脱氧葡萄糖（[F]FDG，0.020mSv/MBq）。
本研究证明了[Cu]FBP8探针具有以下特性：剂量学估计值低；血液清除迅速且经肾脏排泄；背景信号低；以及单次检查可在20分钟内完成全身采集。这些特性为[Cu]FBP8成为纤维蛋白全身无创成像的优秀候选者奠定了基础，纤维蛋白是许多心血管、肿瘤和神经疾病中的重要驱动因素/特征。
