Exploratory Evaluation of [11C]-NOP46

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03705819
• Other study ID #: AAAQ8138
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 25, 2019
• Est. completion date: March 2025

Study information

• Verified date: October 2023
• Source: Columbia University
• Contact: Mikhail Doubrovin, MD
• Phone: +1 212 342 0555
• Email: md2367[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• [11C]-NOP46
Subjects will receive a microdose (=10 µg) of [11C]-NOP46.

Radiation:
• PET/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.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Akiva Mintz

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	48 hours post-scan
Secondary	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	48 hours post-scan