Back to results

Exploratory Evaluation of [11C]-NOP46

Primary Purpose

Chronic Pain

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

[11C]-NOP46

PET/CT scan

About this trial

This is an interventional other trial for Chronic Pain focused on measuring [11C]-NOP46

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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participants who have taken pain medication within 48 hours of agent administration may be either withdrawn from the study or rescheduled at the PI's discretion).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.

Sites / Locations

Columbia University Irving Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Healthy Volunteers

Individuals with Focal Pain

Arm Description

In 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.

In 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03705819

First Posted

October 10, 2018

Last Updated

October 9, 2022

Sponsor

Akiva Mintz

1. Study Identification

Unique Protocol Identification Number

NCT03705819

Brief Title

Exploratory Evaluation of [11C]-NOP46

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 25, 2019 (Actual)

Primary Completion Date

March 2025 (Anticipated)

Study Completion Date

March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Akiva Mintz

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain

Keywords

[11C]-NOP46

7. Study Design

Primary Purpose

Other

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Masking Description

Open Label Study

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy Volunteers

Arm Type

Experimental

Arm Description

Arm Title

Individuals with Focal Pain

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

[11C]-NOP46

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

PET/CT scan

Intervention Description

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.

Primary Outcome Measure Information:

Title

Uptake ratio for site with pain is >1

Description

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

Time Frame

48 hours post-scan

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

48 hours post-scan

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mikhail Doubrovin, MD

Phone

+1 212 342 0555

md2367@cumc.columbia.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Rodolfo Arevalo

Phone

212-342-1683

ra2874@cumc.columbia.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Akiva Mintz, MD, PhD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Irving Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Akiva Mintz, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Final data analysis and conclusion will be submitted to scientific journals and made available for publication.

Citations:

PubMed Identifier

21148657

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.

Results Reference

background

PubMed Identifier

22110936

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.

Results Reference

background

PubMed Identifier

22048730

Citation

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.

Results Reference

background

PubMed Identifier

19616318

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.

Results Reference

background

Learn more about this trial

Exploratory Evaluation of [11C]-NOP46

We'll reach out to this number within 24 hrs