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[11C]-NOP46 PET/CT Scan for Chronic Pain

Phase < 1

Recruiting

Led By Akiva Mintz, MD, PhD

Research Sponsored by Akiva Mintz

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For Patients with Focal Pain: Subjects must have current pain from a focal injury for which they are under a physician's care.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours post-scan

Awards & highlights

Study Summary

This trialwill test the safety and effectiveness of an experimental radiotracer to detect chronic pain in 30 patients. The first 5 participants will receive a tiny dose and have a CT scan.

Who is the study for?

This trial is for adults who can consent to participate. Healthy volunteers must not have chronic pain or be pregnant, and agree to use contraception. Patients with focal pain should experience moderate to severe pain (>4 on the Visual Analogue Scale) and also agree to contraceptive measures.Check my eligibility

What is being tested?

The study tests a new radiotracer called [11C]-NOP46 using PET/CT scans in two stages: first in five healthy individuals for safety, then in thirty patients with chronic pain if no toxicities are found.See study design

What are the potential side effects?

Potential side effects aren't specified but will be monitored during the initial safety evaluation of the radiotracer [11C]-NOP46 in healthy participants before proceeding with patients having chronic pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently experiencing pain from a specific injury and am seeing a doctor for it.

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I am 18 or older and can understand and sign a consent form.

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I am a volunteer without any ongoing pain from an injury.

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My pain level is more than 4 on a scale of 0 to 10.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours post-scan

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours post-scan

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours post-scan for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Uptake ratio for site with pain is >1

Secondary outcome measures

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Individuals with Focal PainExperimental Treatment2 Interventions

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.

Group II: Healthy VolunteersExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PET/CT scan

2013

Completed Phase 1

~340

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Akiva MintzLead Sponsor

Akiva Mintz, MD, PhDPrincipal Investigator - Columbia University

Columbia University

Media Library

[11C]-NOP46 Clinical Trial Eligibility Overview. Trial Name: NCT03705819 — Phase < 1

Chronic Pain Research Study Groups: Individuals with Focal Pain, Healthy Volunteers

Chronic Pain Clinical Trial 2023: [11C]-NOP46 Highlights & Side Effects. Trial Name: NCT03705819 — Phase < 1

[11C]-NOP46 2023 Treatment Timeline for Medical Study. Trial Name: NCT03705819 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any criteria or restrictions for participants of this medical trial?

"To gain entry to this medical trial, a participant should be enduring chronic pain and between 18-90 years old. Approximately 40 individuals will have the opportunity to join."

Answered by AI

Is this inquiry actively recruiting participants?

"Clinicaltrials.gov reports that this medical trial is still enrolling members, having been initially posted on March 25th 2019 and modified most recently on October 9th 2022."

Answered by AI

Is there an age limit on participants of this experiment?

"The terms of entry for this medical trial stipulate that participants must be of legal age (18+) and under the elderly benchmark (90)."

Answered by AI

What is the enrollment quota for this clinical trial?

"Absolutely. According to information available on clinicaltrials.gov, the experiment which was first posted back in March 25th 2019 is currently recruiting participants and seeks 40 volunteers from one medical centre. The study has been most recently updated on October 9th 2022."

Answered by AI