The objective of this study is to assess two novel positron emission tomography (PET) radiotracers, \[64Cu\]CM500 and \[68Ga\]CM500, for Positron Emission Tomography-Magnetic Resonance Imaging (PET-MR) and Positron Emission Tomography / Computed Tomography (PET-CT) imaging of solid tumors. These tracers have the potential to detect solid tumors throughout the body and may enable doctors to identify smaller tumors than conventional imaging techniques.
The primary objectives of this study are: 1. To evaluate the safety of \[64Cu\]CM500 and \[68Ga\]CM500 and their whole-body distribution, metabolism, pharmacokinetics, and radiation burden in healthy volunteers. 2. To measure the distribution of \[64Cu\]CM500 and \[68Ga\]CM500 PET in patients with different types of cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
40
\[64Cu\]CM500 is a peptide-based PET radiopharmaceutical. \[64Cu\]CM500 is administered intravenously (IV)
\[68Ga\]CM500 is a peptide-based PET radiopharmaceutical. \[68Ga\]CM500 is administered intravenously (IV)
Whole body imaging using a PET/MR scanner
Whole body imaging using a PET/CT scanner
A total of 9 cc of blood sampled before, during, and after imaging for clinical chemistry
Massachussetts General Hospital
Boston, Massachusetts, United States
BAMF Health
Grand Rapids, Michigan, United States
East River Medical Imaging
New York, New York, United States
Pharmacokinetics of the PET radiopharmaceuticals [64Cu]CM500 and [68Ga]CM500 in healthy volunteers through measurement of radioactivity in blood
Time frame: 48 hours
Standardized uptake value
The standardized uptake value (SUV) of \[64Cu\]CM500 and \[68Ga\]CM500 in solid tumors and in the various organs of interest (heart, liver, spleen, kidney, lung and any other organ that exhibits uptake) will be collected.
Time frame: 36 hours
Dosimetry and radiation burden of [64Cu]CM500 and [68Ga]CM500
Organs assessed include, but are not limited to, the heart, liver, spleen, kidney, and urinary bladder.
Time frame: 36 hours
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