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

NCT04510311 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-01-10

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • David Raffel, Ph.D. · University of Michigan Rogel Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-19
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04510311 on ClinicalTrials.gov