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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04510311
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Michigan Rogel Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

David Raffel, Ph.D.
Principal Investigator Affiliation University of Michigan Rogel Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neuroendocrine Tumors
Additional Details

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.

Arms & Interventions

Arms

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

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

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).

Interventions

Drug: - 3-[18F]Fluoro-para-hydroxyphenethylguanidine

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

Drug: - [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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109

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