64Cu/68Ga Labeled CM500 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults who are either healthy volunteers or have been diagnosed with various types of solid tumors, such as cancers of the kidney, liver, pancreas, bladder, breast, throat, brain, colon, esophagus, stomach, mouth, lung, ovary or prostate. Specific inclusion and exclusion criteria apply.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- [64Cu]CM500
- [68Ga]CM500
Trial Overview
The study is testing two new imaging agents ([64Cu]CM500 and [68Ga]CM500) used in PET/MR and PET/CT scans to see how well they help detect solid tumors compared to standard methods. Blood samples will also be collected for analysis.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Up to thirty-four (34) cancer patients will be injected with \[68Ga\]CM500 and then undergo PET/CT or PET/MR. Patient subjects will undergo blood collection before and after the scan.
Up to thirty-four (34) cancer patients will be injected with \[64Cu\]CM500 and then undergo PET/CT or PET/MR. Patient subjects will undergo blood collection before and after the scan.
Up to six (6) healthy adult subjects will be injected with \[68Ga\]CM500 to establish the safety, whole body distribution, metabolism, pharmacokinetics, and radiation burden of the probe. All subjects will be imaged using PET/MR or PET/CT. Healthy subjects will undergo blood collection before, during, and after the scan. An interim review of the data will be conducted after the first three subjects receive the study agent and complete all safety assessments
Up to six (6) healthy adult subjects will be injected with \[64Cu\]CM500 to establish the safety, whole body distribution, metabolism, pharmacokinetics, and radiation burden of the probe. All subjects will be imaged using Positron Emission Tomography-Magnetic Resonance Imaging (PET/MR) or Positron Emission Tomography / Computed Tomography (PET/CT). Healthy subjects will undergo blood collection before, during, and after the scan. An interim review of the data will be conducted after the first three subjects receive the study agent and complete all safety assessments.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lumina Pharmaceuticals Inc
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
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