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

Neuroendocrine Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04510311
• Other study ID #: UMCC 2019.174
• Secondary ID: HUM00167104UM-FH
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 19, 2020
• Est. completion date: April 2024

Study information

• Verified date: December 2023
• Source: University of Michigan Rogel Cancer Center
• Contact: David Raffel, Ph.D.
• Phone: 734-936-0725
• Email: raffel[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, a-methyldopa, clonidine

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

Drug:
• 3-[18F]Fluoro-para-hydroxyphenethylguanidine
Single IV injection of 12.0 mCi (+/- 10%) [18F]3F-PHPG
• [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
• Planar scintigraphy scan
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
SPECT/CT scan of the primary neuroendocrine tumor performed the day after IV injection of [123I]MIBG

Locations

Country	Name	City	State
United States	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Image quality assessed by standardized uptake values	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.	Up to 180 minutes
Primary	Biodistribution of [18F]3F-PHPG	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).	90 minutes and 180 minutes after administration of tracer