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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
32
Single IV injection of 12.0 mCi (+/- 10%) \[18F\]3F-PHPG
Single IV injection of 10.0 mCi \[123I\]MIBG
Whole-body PET/CT scan performed at two time-points: 1.5 hours and 3 hours after IV injection of \[18F\]3F-PHPG
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Image quality assessed by standardized uptake values
The maximum standardized uptake value (SUVmax) of \[18F\]3F-PHPG in neoplastic lesions will be quantified from the PET images using region-of-interest (ROI) analysis.
Time frame: Up to 180 minutes
Biodistribution of [18F]3F-PHPG
Changes in the measured tissue concentrations (kBq/cc) of \[18F\]3F-PHPG in neoplastic lesions and abdominal organs from the two acquired PET images (acquired at 90 min and 180 min after tracer injection).
Time frame: 90 minutes and 180 minutes after administration of tracer
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Whole-body scan using planar scintigraphy with a gamma camera performed the day after IV injection of \[123I\]MIBG
SPECT/CT scan of the primary neuroendocrine tumor performed the day after IV injection of \[123I\]MIBG