Imaging Properties of PET Radiotracer [18F]3F-PHPG in Patients With Neuroendocrine Tumors
NCT ID: NCT04510311
Last Updated: 2025-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
32 participants
INTERVENTIONAL
2020-10-19
2024-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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PET/CT scan with radiotracer [18F]3F-PHPG
Novel radiotracer \[18F\]3F-PHPG prior to whole-body PET/CT scan.
3-[18F]Fluoro-para-hydroxyphenethylguanidine
Single IV injection of 12.0 mCi (+/- 10%) \[18F\]3F-PHPG
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/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).
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
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
Interventions
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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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to lie flat for 60 minutes
* Provision of informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Michigan Rogel Cancer Center
OTHER
Responsible Party
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Principal Investigators
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David Raffel, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Rogel Cancer Center
Locations
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University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00167104
Identifier Type: OTHER
Identifier Source: secondary_id
UM-FHPG-03
Identifier Type: OTHER
Identifier Source: secondary_id
UMCC 2019.174
Identifier Type: -
Identifier Source: org_study_id
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