Imaging Properties of PET Radiotracer [18F]3F-PHPG in Patients With Neuroendocrine Tumors

University of Michigan Rogel Cancer Center

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Neuroendocrine Tumors

Treatments: Diagnostic Test: Single photon emission computed tomography/computed tomography scan; Drug: 3-[18F]Fluoro-para-hydroxyphenethylguanidine; Diagnostic Test: Positron emission tomography/computed tomography scan; Drug: [123I] metaiodobenzylguanidine; Diagnostic Test: Planar scintigraphy scan

Study type: Interventional

Funder types: Other

Identifiers

NCT04510311

HUM00167104 (Other Identifier)

UM-FHPG-03 (Other Identifier)

UMCC 2019.174

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current neuroendocrine tumor diagnosis
• Able to lie flat for 60 minutes
• Provision of informed consent

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

PET/CT scan with radiotracer [18F]3F-PHPG

Experimental group

Description:

Novel radiotracer \[18F\]3F-PHPG prior to whole-body PET/CT scan.

Treatment:

Diagnostic Test: Positron emission tomography/computed tomography scan

Drug: 3-[18F]Fluoro-para-hydroxyphenethylguanidine

Planar scintigraphy/SPECT scans with radiotracer [123I]MIBG

Active Comparator group

Description:

FDA approved radiotracer \[123I\]MIBG prior to whole-body planar scintigraphy and SPECT/CT scan (standard clinical imaging procedures).

Treatment:

Diagnostic Test: Planar scintigraphy scan

Drug: [123I] metaiodobenzylguanidine

Diagnostic Test: Positron emission tomography/computed tomography scan

Diagnostic Test: Single photon emission computed tomography/computed tomography scan

Drug: 3-[18F]Fluoro-para-hydroxyphenethylguanidine