Human biodistribution and radiation dosimetry for the tau tracer [18F]Florzolotau in healthy subjects

IF 4.4 Q1 CHEMISTRY, INORGANIC & NUCLEAR

EJNMMI Radiopharmacy and Chemistry Pub Date : 2024-04-02 DOI:10.1186/s41181-024-00259-x

Kun-Ju Lin, Shao-Yi Huang, Kuo-Lun Huang, Chin-Chang Huang, Ing-Tsung Hsiao

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Abstract

Background

Tau pathology plays a crucial role in neurodegeneration diseases including Alzheimer’s disease (AD) and non-AD diseases such as progressive supranuclear palsy. Tau positron emission tomography (PET) is an in-vivo and non-invasive medical imaging technique for detecting and visualizing tau deposition within a human brain. In this work, we aim to investigate the biodistribution of the dosimetry in the whole body and various organs for the [¹⁸F]Florzolotau tau-PET tracer. A total of 12 healthy controls (HCs) were enrolled at Chang Gung Memorial Hospital. All subjects were injected with approximately 379.03 ± 7.03 MBq of [¹⁸F]Florzolotau intravenously, and a whole-body PET/CT scan was performed for each subject. For image processing, the VOI for each organ was delineated manually by using the PMOD 3.7 software. Then, the time-activity curve of each organ was acquired by optimally fitting an exponential uptake and clearance model using the least squares method implemented in OLINDA/EXM 2.1 software. The absorbed dose for each target organ and the effective dose were finally calculated.

Results

From the biodistribution results, the elimination of [¹⁸F]Florzolotau is observed mainly from the liver to the intestine and partially through the kidneys. The highest organ-absorbed dose occurred in the right colon wall (255.83 μSv/MBq), and then in the small intestine (218.67 μSv/MBq), gallbladder wall (151.42 μSv/MBq), left colon wall (93.31 μSv/MBq), and liver (84.15 μSv/MBq). Based on the ICRP103, the final computed effective dose was 34.9 μSv/MBq with CV of 10.07%.

Conclusions

The biodistribution study of [¹⁸F]Florzolotau demonstrated that the excretion of [¹⁸F]Florzolotau are mainly through the hepatobiliary and gastrointestinal pathways. Therefore, a routine injection of 370 MBq or 185 MBq of [¹⁸F]Florzolotau leads to an estimated effective dose of 12.92 or 6.46 mSv, and as a result, the radiation exposure to the whole-body and each organ remains within acceptable limits and adheres to established constraints.

Trial registration

Retrospectively Registered at Clinicaltrials.gov (NCT03625128) on 12 July, 2018, https://clinicaltrials.gov/study/NCT03625128.

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在健康受试者体内进行tau示踪剂[18F]Florzolotau的人体生物分布和辐射剂量测定。

背景：Tau 病理学在包括阿尔茨海默病（AD）和进行性核上性麻痹等非 AD 疾病在内的神经变性疾病中起着至关重要的作用。Tau正电子发射断层扫描（PET）是一种体内无创医学成像技术，可用于检测和观察人脑内的Tau沉积。在这项工作中，我们旨在研究[18F]Florzolotau tau-PET示踪剂在全身和各器官中的生物剂量学分布。我们在长庚纪念医院共招募了12名健康对照组（HCs）。所有受试者均静脉注射了约379.03 ± 7.03 MBq的[18F]Florzolotau，并对每个受试者进行了全身PET/CT扫描。图像处理时，使用 PMOD 3.7 软件手动划分每个器官的 VOI。然后，使用 OLINDA/EXM 2.1 软件中的最小二乘法优化拟合指数摄取和清除模型，获得各器官的时间-活性曲线。最后计算出每个靶器官的吸收剂量和有效剂量：从生物分布结果来看，[18F]氟卓陶主要从肝脏进入肠道，部分通过肾脏排出体外。器官吸收剂量最高的部位是右结肠壁（255.83 μSv/MBq），然后是小肠（218.67 μSv/MBq）、胆囊壁（151.42 μSv/MBq）、左结肠壁（93.31 μSv/MBq）和肝脏（84.15 μSv/MBq）。根据 ICRP103，最终计算的有效剂量为 34.9 μSv/MBq，CV 为 10.07%：[18F]氟唑腙的生物分布研究表明，[18F]氟唑腙主要通过肝胆和胃肠途径排泄。因此，常规注射370 MBq或185 MBq的[18F]氟唑腙，估计有效剂量为12.92或6.46 mSv，因此，全身和各器官受到的辐射量仍在可接受的范围内，并符合既定的限制条件：回顾性注册于2018年7月12日的Clinicaltrials.gov（NCT03625128），https://clinicaltrials.gov/study/NCT03625128 。

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