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PET Radiotracer Imaging for Neuroendocrine Cancer

Phase < 1
Waitlist Available
Led By David Raffel, Ph.D.
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current neuroendocrine tumor diagnosis
Be older than 18 years old
Must not have
- Tetrabenazine (Xenazine), which inhibits the VMAT2 transporter
- Cold medications containing the sympathomimetic amines: phenylephrine, phenylpropanolamine, pseudoephedrine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 minutes and 180 minutes after administration of tracer
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new method to map and stage neuroendocrine tumors. If successful, this could help doctors treat these tumors more effectively in the future.

Who is the study for?
This trial is for individuals with neuroendocrine tumors who can lie flat for an hour and give informed consent. It's not suitable for those on certain medications like tricyclic antidepressants, cocaine, some blood pressure drugs, nasal decongestants, cold medicines with sympathomimetic amines, tetrabenazine or MAOIs; nor pregnant or breastfeeding women or people with claustrophobia.
What is being tested?
The study tests if [18F]3F-PHPG PET scans are effective in locating neuroendocrine tumors compared to existing imaging methods like SPECT/CT scans and planar scintigraphy. The aim is to potentially establish [18F]3F-PHPG as a standard tool for tumor localization and staging.
What are the potential side effects?
While the document doesn't list specific side effects of [18F]3F-PHPG, generally PET scan tracers may cause allergic reactions or discomfort at the injection site. Imaging procedures involve lying still which might be uncomfortable.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a neuroendocrine tumor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking Xenazine for my condition.
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I am not taking cold medicines with phenylephrine, phenylpropanolamine, or pseudoephedrine.
Select...
I am not taking any MAOI medications.
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I cannot lie flat for an hour.
Select...
I do not use cocaine.
Select...
I am not taking reserpine, labetalol, α-methyldopa, or clonidine for high blood pressure.
Select...
I am currently using nasal decongestants.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 minutes and 180 minutes after administration of tracer
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 minutes and 180 minutes after administration of tracer for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Biodistribution of [18F]3F-PHPG
Image quality assessed by standardized uptake values

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PET/CT scan with radiotracer [18F]3F-PHPGExperimental Treatment2 Interventions
Novel radiotracer \[18F\]3F-PHPG prior to whole-body PET/CT scan.
Group II: Planar scintigraphy/SPECT scans with radiotracer [123I]MIBGActive Control5 Interventions
FDA approved radiotracer \[123I\]MIBG prior to whole-body planar scintigraphy and SPECT/CT scan (standard clinical imaging procedures).

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
300 Previous Clinical Trials
21,183 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
116 Patients Enrolled for Neuroendocrine Tumors
David Raffel, Ph.D.Principal InvestigatorUniversity of Michigan Rogel Cancer Center

Media Library

Positron emission tomography/computed tomography scan Clinical Trial Eligibility Overview. Trial Name: NCT04510311 — Phase < 1
Neuroendocrine Tumors Research Study Groups: Planar scintigraphy/SPECT scans with radiotracer [123I]MIBG, PET/CT scan with radiotracer [18F]3F-PHPG
Neuroendocrine Tumors Clinical Trial 2023: Positron emission tomography/computed tomography scan Highlights & Side Effects. Trial Name: NCT04510311 — Phase < 1
Positron emission tomography/computed tomography scan 2023 Treatment Timeline for Medical Study. Trial Name: NCT04510311 — Phase < 1
~6 spots leftby Dec 2025
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