An Exploratory Study of 3-[18F]Fluoro-para-hydroxyphenethylguanidine ([18F]3F-PHPG) in Patients With Neuroendocrine Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Image quality assessed by standardized uptake values
研究概览
简要总结
The goal of this exploratory study is to test whether [18F]3F-PHPG can be used reliably to map the locations of tumors in patients with neuroendocrine tumors. If so, the results of this study will be used to support further development of [18F]3F-PHPG as a clinical tool for neuroendocrine tumor localization and staging.
详细描述
Subjects enrolled in this study will be recruited from the population of adult patients with neuroendocrine tumors, including pheochromocytoma and paraganglioma, being treated at the University of Michigan Hospital.
The primary objective of the study is to obtain basic information on the biodistribution and pharmacokinetics of [18F]3F-PHPG in cancer patients with neuroendocrine tumors.
The secondary objective of the study is to compare the diagnostic performance of [18F]3F-PHPG in cancer patients with neuroendocrine tumors with the FDA approved radiopharmaceuticals [123I]metaiodobenzylguanidine ([123I]MIBG) and [68Ga]DOTA-TATE in the same patients. A group of approximately 12 of the subjects scanned with [18F]3F-PHPG will be recruited to undergo a whole-body [123I]MIBG scan using planar scintigraphy with a gamma camera, following the standard clinical protocol used at the University of Michigan. In addition, a single SPECT/CT scan of the primary neuroendocrine tumor will be acquired after the whole-body scan to provide a tomographic image for comparison with the positron emission tomography (PET) image acquired using [18F]3F-PHPG. Several subjects enrolled on this study will undergo [68Ga]DOTA-TATE scans off-study, as part of routine clinical management. Existing [68Ga]DOTA-TATE scans will be obtained from consenting subjects' medical records.
This is an exploratory study and thus all statistical data analyses will be exploratory in nature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current neuroendocrine tumor diagnosis
- •Able to lie flat for 60 minutes
- •Provision of informed consent
排除标准
- •Pregnancy or lactation
- •Claustrophobia
- •Inability to lie flat for 60 minutes
- •Currently taking medications that may alter PET scans of neuroendocrine tumors with these tracers, including any of the following:
- •Tricyclic antidepressants, which inhibit the norepinephrine transporter: desipramine, amitriptyline, imipramine
- •Cold medications containing the sympathomimetic amines: phenylephrine, phenylpropanolamine, pseudoephedrine
- •Nasal decongestants (some use phenylephrine as the active agent)
- •Cocaine (which inhibits the norepinephrine transporter)
- •Tetrabenazine (Xenazine), which inhibits the VMAT2 transporter
- •Monoamine oxidase inhibitors (MAOI)
- •Some antihypertensive drugs: reserpine, labetalol, α-methyldopa, clonidine
研究组 & 干预措施
PET/CT scan with radiotracer [18F]3F-PHPG
Novel radiotracer [18F]3F-PHPG prior to whole-body PET/CT scan.
干预措施: Positron emission tomography/computed tomography scan (Diagnostic Test)
PET/CT scan with radiotracer [18F]3F-PHPG
Novel radiotracer [18F]3F-PHPG prior to whole-body PET/CT scan.
干预措施: 3-[18F]Fluoro-para-hydroxyphenethylguanidine (Drug)
Planar scintigraphy/SPECT scans with radiotracer [123I]MIBG
FDA approved radiotracer [123I]MIBG prior to whole-body planar scintigraphy and SPECT/CT scan (standard clinical imaging procedures).
干预措施: [123I] metaiodobenzylguanidine (Drug)
Planar scintigraphy/SPECT scans with radiotracer [123I]MIBG
FDA approved radiotracer [123I]MIBG prior to whole-body planar scintigraphy and SPECT/CT scan (standard clinical imaging procedures).
干预措施: Positron emission tomography/computed tomography scan (Diagnostic Test)
Planar scintigraphy/SPECT scans with radiotracer [123I]MIBG
FDA approved radiotracer [123I]MIBG prior to whole-body planar scintigraphy and SPECT/CT scan (standard clinical imaging procedures).
干预措施: Single photon emission computed tomography/computed tomography scan (Diagnostic Test)
Planar scintigraphy/SPECT scans with radiotracer [123I]MIBG
FDA approved radiotracer [123I]MIBG prior to whole-body planar scintigraphy and SPECT/CT scan (standard clinical imaging procedures).
干预措施: Planar scintigraphy scan (Diagnostic Test)
Planar scintigraphy/SPECT scans with radiotracer [123I]MIBG
FDA approved radiotracer [123I]MIBG prior to whole-body planar scintigraphy and SPECT/CT scan (standard clinical imaging procedures).
干预措施: 3-[18F]Fluoro-para-hydroxyphenethylguanidine (Drug)
结局指标
主要结局
Image quality assessed by standardized uptake values
时间窗: Up to 180 minutes
The maximum standardized uptake value (SUVmax) of \[18F\]3F-PHPG in neoplastic lesions will be quantified from the PET images using region-of-interest (ROI) analysis.
Biodistribution of [18F]3F-PHPG
时间窗: 90 minutes and 180 minutes after administration of tracer
Changes in the measured tissue concentrations (kBq/cc) of \[18F\]3F-PHPG in neoplastic lesions and abdominal organs from the two acquired PET images (acquired at 90 min and 180 min after tracer injection).
次要结局
未报告次要终点