Exploratory Evaluation of [11C]-NOP46

Last updated: April 9, 2025
Sponsor: Columbia University
Overall Status: Completed

Phase

1

Condition

Pain

Chronic Pain

Treatment

[11C]-NOP46

PET/CT scan

Clinical Study ID

NCT03705819
AAAQ8138
  • Ages 18-90
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All subjects must be 18 years of age or older, able to read, understand, andvoluntarily sign an informed consent document.

For Healthy Volunteers:

  • Volunteers must have no current medical history of sustained pain from a focalinjury.

  • 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 andfor the duration of study participation.

Patients with Focal Pain:

  • Subjects must have current pain from a focal injury for which they are under aphysician's care.

  • Subjects must have moderate to severe pain, defined as >4 on the Visual AnalogueScale

  • 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 andfor the duration of study participation.

Exclusion

Exclusion Criteria:

  • Participants with evidence of diffuse pain at the time of enrollment up to agentadministration are to be excluded from this study.

  • Inability to discontinue pain medication(s) for 48 hours prior to agentadministration.(Enrolled participants who have taken pain medication within 48 hoursof agent administration may be either withdrawn from the study or rescheduled at thePI's discretion).

  • Concomitant medication use (including suspected illicit drugs use) that, in thejudgment of the investigator, would make the participant inappropriate forenrollment.

  • Severe concurrent disease, infection, or medical co-morbidity that, in the judgmentof 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.

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: [11C]-NOP46
Phase: 1
Study Start date:
March 25, 2019
Estimated Completion Date:
October 30, 2023

Study 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.

Connect with a study center

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

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