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NCT Number: NCT04510311

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3-[18F]Fluoro-para-hydroxyphenethylguanidine

Drug

Single IV injection of 12.0 mCi (+/- 10%) [18F]3F-PHPG

Other names: [18F]3F-PHPG

[123I] metaiodobenzylguanidine

Drug

Single IV injection of 10.0 mCi [123I]MIBG

Other names: [123I]MIBG, AdreView™

Positron emission tomography/computed tomography scan

Diagnostic Test

Whole-body PET/CT scan performed at two time-points: 1.5 hours and 3 hours after IV injection of [18F]3F-PHPG

Other names: PET/CT

Planar scintigraphy scan

Diagnostic Test

Whole-body scan using planar scintigraphy with a gamma camera performed the day after IV injection of [123I]MIBG

Single photon emission computed tomography/computed tomography scan

Diagnostic Test

SPECT/CT scan of the primary neuroendocrine tumor performed the day after IV injection of [123I]MIBG

Other names: SPECT/CT scan

Primary outcomes

  1. Image quality assessed by standardized uptake values

    Time frame: 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.

  2. Biodistribution of [18F]3F-PHPG

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Registry information

Official study title

An Exploratory Study of 3-[18F]Fluoro-para-hydroxyphenethylguanidine ([18F]3F-PHPG) in Patients With Neuroendocrine Tumors

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 12, 2020
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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