Columbia University Irving Medical Center
New York, 10032, United States
NCT Number: NCT03705819
This is an open-label, single center design. In the first stage, five (5) healthy individuals will receive a microdose (10µg) of [11C]-NOP46, immediately followed by whole body positron emission tomography (PET)/computed tomography (CT) to determine dosimetry and perform an initial safety evaluation of the radiotracer. If no toxicities develop, then the investigation will move to the second stage, in which thirty (30) patients with chronic pain will receive a microdose of [11C]-NOP46 followed by PET/CT of region of interests.
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Notify Me18 year–90 year
All sexes
Interventional
Early Phase 1
New York, 10032, United States
Pain is a natural response to injury. Pain lets us know there may be damage to our bodies. Pain is the way our body tells us that we must take care of ourselves. Chronic pain is different. Chronic pain is pain that lasts for a long time. Chronic pain can last for weeks, months, and even years. In some cases chronic pain remains without any sign of body damage. Today, there is no way for a doctor to measure someone's chronic pain or accurately determine many details about chronic pain. The investigators at Columbia University are interested in new imaging test that could help doctors look at chronic pain and help patients with chronic pain. The new imaging test uses a new drug called [11C]-NOP46. [11C]-NOP46 is a radioactive drug and is experimental. It is not approved by the Food and Drug Administration (FDA). The investigators believe that, when given to patients, this new drug can go to the exact places of chronic pain within the body. Once the drug goes to the places of chronic pain, a special camera, called a Positron Emission Tomography (PET) camera, can be used to take pictures of the drug. In this study, the investigators will give [11C]-NOP46 to up to 35 subjects.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For Healthy Volunteers:
Patients with Focal Pain:
Exclusion criteria
Subjects will receive a microdose (≤10 µg) of [11C]-NOP46.
After subjects receive a microdose of [11C]-NOP46, whole body PET/CT scan(s) will be performed to determine dosimetry and perform an initial safety evaluation of the radiotracer in Stage 1 and region of interests in Stage 2.
Time frame: 48 hours post-scan
The uptake ratio for the site with pain to the site without pain is greater than 1 in the focal pain subjects
Time frame: 48 hours post-scan
Total number of physiologic effects associated with a single micro-dose administration of [11C]-NOP46
Columbia University
Other
Exploratory Evaluation of [11C]-NOP46 Pharmacokinetics With Positron Emission Tomography (PET)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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