Lumina Pharmaceuticals Inc
The objective of this study is to assess two novel positron emission tomography (PET) radiotracers, \[64Cu\]CM500 and \[68Ga\]CM500, for PET-MR and 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.
Inclusion Criteria: * For healthy subjects: * 18 years of age or older; * Deemed healthy at screening visit based on the following assessments: physical examination, height and weight, medical history, and blood pressure, pulse, temperature, pulse oximetry, heart rhythm, and respiratory rate. labs within the previous month can be utilized to determine eligibility; * No known history of atrial fibrillation with CHA₂DS₂-VASc score of 1 or higher, or history of thrombosis; * Negative drug screen; * Have the ability to give written informed consent. * For patient subjects with presence…
\[64Cu\]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