Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04510311
Recruitment Status : Recruiting
First Posted : August 12, 2020
Last Update Posted : December 17, 2021
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors 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 Early Phase 1

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Exploratory Study of 3-[18F]Fluoro-para-hydroxyphenethylguanidine ([18F]3F-PHPG) in Patients With Neuroendocrine Tumors
Actual Study Start Date : October 19, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: [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 Name: 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 Name: [18F]3F-PHPG

Drug: [123I] metaiodobenzylguanidine
Single IV injection of 10.0 mCi [123I]MIBG
Other Names:
  • [123I]MIBG
  • AdreView™

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 Name: PET/CT

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 Name: SPECT/CT scan


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510311


Contacts
Layout table for location contacts
Contact: David Raffel, Ph.D. 734-936-0725 raffel@umich.edu

Locations
Layout table for location information
United States, Michigan
University of Michigan Rogel Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: David Raffel, Ph.D.         
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: David Raffel, Ph.D. University of Michigan Rogel Cancer Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT04510311    
Other Study ID Numbers: UMCC 2019.174
HUM00167104 ( Other Identifier: University of Michigan )
UM-FHPG-03 ( Other Identifier: University of Michigan )
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: December 17, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
 3-Iodobenzylguanidine
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals