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

NCT04510311 | Completed Early Phase 1 FDA Drug

• 3 other identifiers: UMCC 2019.174HUM00167104UM-FHPG-03
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

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

EXPERIMENTAL

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

Drug: 3-[18F]Fluoro-para-hydroxyphenethylguanidine; Diagnostic Test: Positron emission tomography/computed tomography scan

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

ACTIVE COMPARATOR

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

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

Interventions

[123I] metaiodobenzylguanidine DRUG

Single IV injection of 10.0 mCi \[123I\]MIBG

Also known as: [123I]MIBG, AdreView™

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

Planar scintigraphy scan DIAGNOSTIC_TEST

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

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

3-[18F]Fluoro-para-hydroxyphenethylguanidine DRUG

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

Also known as: [18F]3F-PHPG

PET/CT scan with radiotracer [18F]3F-PHPG; Planar scintigraphy/SPECT scans with radiotracer [123I]MIBG

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

Also known as: PET/CT

PET/CT scan with radiotracer [18F]3F-PHPG; Planar scintigraphy/SPECT scans with radiotracer [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

Also known as: SPECT/CT scan

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Iodine-123; 3-Iodobenzylguanidine; Positron-Emission Tomography; Tomography, X-Ray Computed; Positron Emission Tomography Computed Tomography; Tomography, Emission-Computed, Single-Photon; Single Photon Emission Computed Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Iodobenzenes; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Hydrocarbons, Iodinated; Hydrocarbons, Halogenated; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope; Radiographic Image Enhancement; Radiography; Tomography, X-Ray; Multimodal Imaging

Study Officials

• David Raffel, Ph.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All subjects (30 anticipated) will receive a PET/CT scan using the novel radiotracer \[18F\]3F-PHPG as an imaging agent. Within 60 days after the \[18F\]3F-PHPG PET/CT scan, approximately 12 of the subjects will also receive an FDA approved radiotracer \[123I\]MIBG one day prior to whole-body planar scintigraphy and SPECT/CT scans. The \[123I\]MIBG scans are standard clinical imaging procedures.

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 12, 2020
• Study Start: October 19, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)