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Chronic PainEarly Phase 1NCT03705819

Exploratory Evaluation of [11C]-NOP46

A Early Phase 1 study testing [11C]-NOP46 and PET/CT scan in people with Chronic Pain, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Pain
What is being tested?
[11C]-NOP46 and PET/CT scan
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
25 Mar 2019to 30 Oct 2023
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Columbia University Irving Medical Center

    New York, New York, 10032

Other trials in United States

About this study

Official title: Exploratory Evaluation of [11C]-NOP46 Pharmacokinetics With Positron Emission Tomography (PET)

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.

Read the 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.

Conditions
Chronic Pain
Being tested
[11C]-NOP46, PET/CT scan
Keywords
[11C]-NOP46
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [11C]-NOP46Drug

    Subjects will receive a microdose (≤10 µg) of [11C]-NOP46.

  • PET/CT scanRadiation

    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.

Study groups in NCT03705819
Study groupRoleWhat they receive
Healthy VolunteersExperimentalIn Stage 1, five healthy volunteers will receive a microdose of [11C]-NOP46 and undergo serial whole body PET/CT scans for up to 240 minutes post-administration. These image sets will be used to evaluate [11C]-NOP46 biodistribution and derive dosimetry estimates.
Receives: Drug: [11C]-NOP46; Radiation: PET/CT scan
Individuals with Focal PainExperimentalIn Stage 2, up to 30 subjects with focal pain will receive a microdose of [11C]-NOP46 and undergo PET/CT scans for up to 60 minutes in length. The results of Stage 1 will inform the scanning parameters (uptake period, scan length, reconstruction parameters, etc.) for Stage 2.
Receives: Drug: [11C]-NOP46; Radiation: PET/CT scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Uptake ratio for site with pain is >1

    The uptake ratio for the site with pain to the site without pain is greater than 1 in the focal pain subjects

    Measured: 48 hours post-scan

Secondary outcomes (1)

  1. Occurrence of Physiologic Effects of Single Micro-dose of [11C]-NOP46

    Total number of physiologic effects associated with a single micro-dose administration of [11C]-NOP46

    Measured: 48 hours post-scan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2018
  2. Study start25 Mar 2019
  3. Primary completion30 Oct 2023
  4. Study completion30 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03705819
Sponsor's protocol ID
AAAQ8138
Status last verified
Apr 2025
First submitted
10 Oct 2018
Last updated
13 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Final data analysis and conclusion will be submitted to scientific journals and made available for publication.

Publications

  • Voscopoulos C, Lema M. When does acute pain become chronic? Br J Anaesth. 2010 Dec;105 Suppl 1:i69-85. doi: 10.1093/bja/aeq323.

    PubMed 21148657

  • Jamison RN, Serraillier J, Michna E. Assessment and treatment of abuse risk in opioid prescribing for chronic pain. Pain Res Treat. 2011;2011:941808. doi: 10.1155/2011/941808. Epub 2011 Oct 11.

    PubMed 22110936

  • Centers for Disease Control and Prevention (CDC). Vital signs: overdoses of prescription opioid pain relievers---United States, 1999--2008. MMWR Morb Mortal Wkly Rep. 2011 Nov 4;60(43):1487-92.

    PubMed 22048730

  • Pike VW. PET radiotracers: crossing the blood-brain barrier and surviving metabolism. Trends Pharmacol Sci. 2009 Aug;30(8):431-40. doi: 10.1016/j.tips.2009.05.005. Epub 2009 Jul 16.

    PubMed 19616318

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing [11C]-NOP46 and PET/CT scan in people with Chronic Pain, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Uptake ratio for site with pain is >1 (time frame: 48 hours post-scan). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03705819, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.

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