NCT04510311

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	3-[18F]Fluoro-para-hydroxyphenethylguanidine	Single IV injection of 12.0 mCi (+/- 10%) \[18F\]3F-PHPG
DRUG	[123I] metaiodobenzylguanidine	Single IV injection of 10.0 mCi \[123I\]MIBG
DIAGNOSTIC_TEST	Positron emission tomography/computed tomography scan	Whole-body PET/CT scan performed at two time-points: 1.5 hours and 3 hours after IV injection of \[18F\]3F-PHPG
DIAGNOSTIC_TEST	Planar scintigraphy scan	Whole-body scan using planar scintigraphy with a gamma camera performed the day after IV injection of \[123I\]MIBG
DIAGNOSTIC_TEST	Single photon emission computed tomography/computed tomography scan	SPECT/CT scan of the primary neuroendocrine tumor performed the day after IV injection of \[123I\]MIBG

Timeline

• Start date: 2020-10-19
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2020-08-12
• Last updated: 2025-01-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study