A Phase I/IIa Clinical Trial to Evaluate Safety and Adrenal Uptake of Para-Chloro-2-[18F]Fluoroethyletomidate in Healthy Volunteers and Patients with Primary Aldosteronism

原发性醛固酮增多症 医学 临床试验 内科学 泌尿科 醛固酮
作者
Daniel Gillett,Russell Senanayake,James MacFarlane,Waiel Bashari,August Palma,Lihua Hu,Inês Harper,Iosif Mendichovszky,Gunnar Antoni,Per Hellman,Anders Sundín,Matthew Hird,István Boros,Morris J. Brown,Heok Cheow,Luigi Aloj,Franklin I. Aigbirhio,Mark Gurnell
出处
期刊:The Journal of Nuclear Medicine [Society of Nuclear Medicine and Molecular Imaging]
卷期号:: jnumed.124.268425-jnumed.124.268425
标识
DOI:10.2967/jnumed.124.268425
摘要

Primary aldosteronism (PA) is a common, potentially reversible, cause of hypertension. Distinguishing unilateral from bilateral PA is critical when deciding who should be offered surgery (unilateral adrenalectomy). Recent studies have shown that PET/CT with [11C]metomidate can accurately identify unilateral PA, with localization of the causative aldosterone-producing adenoma (APA). However, the availability of [11C]metomidate is limited to centers with an on-site cyclotron. Here, we report an early-phase human study with the 18F-labeled analog, para-chloro-2-[18F]fluoroethyletomidate ([18F]CETO). Methods: We conducted a phase I/IIa, single-center, open-label, microdosing study. The primary objective was to evaluate the safety of up to 2 administrations of [18F]CETO in 6 patients with PA (3 unilateral disease, 3 bilateral disease) and 5 healthy volunteers. Safety evaluation included assessment of adrenal function after the first [18F]CETO administration. The biodistribution of [18F]CETO was assessed in a 90-min dynamic PET acquisition. In patients with PA, the effect of pretreatment with oral dexamethasone on [18F]CETO uptake by normal adrenal tissue and APAs was also assessed. Results: Eleven participants were recruited to the trial, including 6 patients and 5 healthy volunteers. No subjects experienced serious adverse events or reactions, and all participants had normal adrenal function after [18F]CETO administration. [18F]CETO demonstrated high selectivity for the adrenal glands with low uptake in other tissues. Visualization of APAs was enhanced after dexamethasone pretreatment, which suppressed [18F]CETO uptake by normal adrenal tissue. Conclusion: [18F]CETO is a safe radiopharmaceutical for PET imaging of the adrenal glands, with no observed adverse reactions or impairment of adrenal function in this study. [18F]CETO demonstrates selective high affinity for adrenal tissue, particularly APAs. Distinction between APAs and normal adrenal tissue is enhanced by dexamethasone pretreatment to suppress [18F]CETO uptake by normal glands. This positions [18F]CETO as a promising imaging tool for evaluation in the context of PA.

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
斯文败类应助kkkkk采纳,获得10
1秒前
2秒前
hlf完成签到,获得积分10
2秒前
2秒前
洁净灭男完成签到,获得积分10
2秒前
CD56应助黄黄采纳,获得20
4秒前
fx发布了新的文献求助20
4秒前
4秒前
大方笑阳完成签到,获得积分10
4秒前
4秒前
4秒前
5秒前
乐乐应助骑驴找马采纳,获得10
6秒前
6秒前
芹菜煎蛋发布了新的文献求助10
7秒前
8秒前
刘菲清发布了新的文献求助10
9秒前
所所应助细心的语蓉采纳,获得10
10秒前
fx完成签到,获得积分20
10秒前
云珂完成签到,获得积分10
11秒前
洁净斑马发布了新的文献求助10
11秒前
11秒前
bkagyin应助跳跃火车采纳,获得10
11秒前
穆亦擎完成签到 ,获得积分10
11秒前
小强发布了新的文献求助10
11秒前
Akim应助科研通管家采纳,获得30
13秒前
ding应助科研通管家采纳,获得10
13秒前
NexusExplorer应助科研通管家采纳,获得10
13秒前
深情安青应助科研通管家采纳,获得20
13秒前
七七完成签到,获得积分10
13秒前
星辰大海应助科研通管家采纳,获得10
13秒前
wu8577应助科研通管家采纳,获得30
13秒前
星辰大海应助科研通管家采纳,获得10
13秒前
14秒前
奋斗发布了新的文献求助10
14秒前
芹菜煎蛋完成签到,获得积分10
15秒前
隐形曼青应助Camille采纳,获得10
15秒前
六五发布了新的文献求助10
16秒前
量子星尘发布了新的文献求助10
17秒前
17秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
Picture Books with Same-sex Parented Families: Unintentional Censorship 500
Nucleophilic substitution in azasydnone-modified dinitroanisoles 500
不知道标题是什么 500
A Preliminary Study on Correlation Between Independent Components of Facial Thermal Images and Subjective Assessment of Chronic Stress 500
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 360
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3971441
求助须知:如何正确求助?哪些是违规求助? 3516161
关于积分的说明 11181180
捐赠科研通 3251322
什么是DOI,文献DOI怎么找? 1795788
邀请新用户注册赠送积分活动 876026
科研通“疑难数据库(出版商)”最低求助积分说明 805228