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

Early Phase 1

Completed

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

• Registration Number: NCT04510311
• Lead Sponsor: University of Michigan Rogel Cancer Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-12
• Study Start: 2020-10-19
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PET/CT scan with radiotracer [18F]3F-PHPG	3-[18F]Fluoro-para-hydroxyphenethylguanidine	Novel radiotracer \[18F\]3F-PHPG prior to whole-body PET/CT scan.
PET/CT scan with radiotracer [18F]3F-PHPG	Positron emission tomography/computed tomography scan	Novel radiotracer \[18F\]3F-PHPG prior to whole-body PET/CT scan.
Planar scintigraphy/SPECT scans with radiotracer [123I]MIBG	3-[18F]Fluoro-para-hydroxyphenethylguanidine	FDA approved radiotracer \[123I\]MIBG prior to whole-body planar scintigraphy and SPECT/CT scan (standard clinical imaging procedures).
Planar scintigraphy/SPECT scans with radiotracer [123I]MIBG	Positron emission tomography/computed tomography scan	FDA approved radiotracer \[123I\]MIBG prior to whole-body planar scintigraphy and SPECT/CT scan (standard clinical imaging procedures).
Planar scintigraphy/SPECT scans with radiotracer [123I]MIBG	Planar scintigraphy scan	FDA approved radiotracer \[123I\]MIBG prior to whole-body planar scintigraphy and SPECT/CT scan (standard clinical imaging procedures).
Planar scintigraphy/SPECT scans with radiotracer [123I]MIBG	Single photon emission computed tomography/computed tomography scan	FDA approved radiotracer \[123I\]MIBG prior to whole-body planar scintigraphy and SPECT/CT scan (standard clinical imaging procedures).
Planar scintigraphy/SPECT scans with radiotracer [123I]MIBG	[123I] metaiodobenzylguanidine	FDA approved radiotracer \[123I\]MIBG prior to whole-body planar scintigraphy and SPECT/CT scan (standard clinical imaging procedures).

Primary Outcome Measures

Name	Time	Method
Image quality assessed by standardized uptake values	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	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).

Trial Locations

Locations (1)

University of Michigan Rogel Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States