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

January 9, 2025 updated by: University of Michigan Rogel Cancer Center

An Exploratory Study of 3-[18F]Fluoro-para-hydroxyphenethylguanidine ([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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Rogel Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PET/CT scan with radiotracer [18F]3F-PHPG
Novel radiotracer [18F]3F-PHPG prior to whole-body PET/CT scan.
Drug: 3-[18F]Fluoro-para-hydroxyphenethylguanidine
Single IV injection of 12.0 mCi (+/- 10%) [18F]3F-PHPG
Other Names:
  • [18F]3F-PHPG
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
Other Names:
  • PET/CT
Active Comparator: Planar scintigraphy/SPECT scans with radiotracer [123I]MIBG
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
Single IV injection of 12.0 mCi (+/- 10%) [18F]3F-PHPG
Other Names:
  • [18F]3F-PHPG
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
Other Names:
  • PET/CT
Drug: [123I] metaiodobenzylguanidine
Single IV injection of 10.0 mCi [123I]MIBG
Other Names:
  • [123I]MIBG
  • AdreView™
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
Other Names:
  • SPECT/CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 180 minutes
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).
90 minutes and 180 minutes after administration of tracer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan Rogel Cancer Center

Investigators

  • Principal Investigator: David Raffel, Ph.D., University of Michigan Rogel Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2020

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 10, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCC 2019.174
  • HUM00167104 (Other Identifier: University of Michigan)
  • UM-FHPG-03 (Other Identifier: University of Michigan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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