Chronic Pain
Conditions
Keywords
[11C]-NOP46
Brief summary
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.
Detailed description
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.
Interventions
DRUG[11C]-NOP46
Subjects will receive a microdose (≤10 µg) of \[11C\]-NOP46.
RADIATIONPET/CT scan
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.
Sponsors
Columbia University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
Open Label Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* All subjects must be 18 years of age or older, able to read, understand, and voluntarily sign an informed consent document. For Healthy Volunteers: * Volunteers must have no current medical history of sustained pain from a focal injury. * Negative pregnancy test if female of childbearing potential. * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Patients with Focal Pain: * Subjects must have current pain from a focal injury for which they are under a physician's care. * Subjects must have moderate to severe pain, defined as \>4 on the Visual Analogue Scale * Subjects must have a negative pregnancy test if female of childbearing potential. * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
Exclusion criteria
* Participants with evidence of diffuse pain at the time of enrollment up to agent administration are to be excluded from this study. * Inability to discontinue pain medication(s) for 48 hours prior to agent administration.(Enrolled participants who have taken pain medication within 48 hours of agent administration may be either withdrawn from the study or rescheduled at the PI's discretion). * Concomitant medication use (including suspected illicit drugs use) that, in the judgment of the investigator, would make the participant inappropriate for enrollment. * Severe concurrent disease, infection, or medical co-morbidity that, in the judgment of the investigator, would make the participant inappropriate for enrollment. * Participants who are receiving any other investigational agents. * Women who are pregnant or breastfeeding. * Subjects who are unable to tolerate PET/CT imaging.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uptake ratio for site with pain is >1 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Physiologic Effects of Single Micro-dose of [11C]-NOP46 | 48 hours post-scan | Total number of physiologic effects associated with a single micro-dose administration of \[11C\]-NOP46 |
Countries
United States
Outcome results
None listed