Exploratory Evaluation of [11C]-NOP46
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.
Conditions:
🦠 Chronic Pain
🗓️ Study Start (Actual) 25 March 2019
🗓️ Primary Completion (Estimated) March 2025
✅ Study Completion (Estimated) March 2025
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase EARLY_PHASE1
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    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participants who have taken pain medication within 48 hours of agent administration may be either withdrawn from the study or rescheduled at the PI's discretion).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.
Ages Eligible for Study: 18 Years to 90 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 10 October 2018
  • First Submitted that Met QC Criteria 10 October 2018
  • First Posted 15 October 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 24 October 2023
  • Last Update Posted 26 October 2023
  • Last Verified October 2023