Imaging Properties of PET Radiotracer [18F]3F-PHPG in Patients With Neuroendocrine Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Neuroendocrine Tumors
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention 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
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 biodistribu...
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.
Tracking Information
- NCT #
- NCT04510311
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: David Raffel, Ph.D. University of Michigan Rogel Cancer Center
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