What side effects are associated with this type of intervention?

Common treatments for chronic pain include opioids, NSAIDs, and gabapentinoids, each with their own side effects. Opioids can cause constipation, nausea, dizziness, and risk of dependency and overdose. NSAIDs are associated with gastrointestinal issues, renal side effects, and increased risk of myocardial infarction. Gabapentinoids, such as gabapentin and pregabalin, can lead to dizziness, fatigue, cognitive difficulties, and visual disturbances. These side effects highlight the need for careful management and monitoring in chronic pain treatment.

What prior FDA approvals exist?

The FDA has approved various treatments for chronic pain, including pharmacologic interventions such as antidepressants (e.g., duloxetine, venlafaxine), anticonvulsants (e.g., pregabalin, gabapentin), and opioids. Additionally, bisphosphonates like zoledronic acid are approved for pain related to bone metastases. While radiotracers like [11C]-NOP46 are being studied for their potential in imaging and managing chronic pain, specific FDA approvals for such radiotracers in chronic pain treatment are not mentioned in the provided context.

What other types of research exist?

Promising alternatives to [11C]-NOP46 for PET/CT imaging in chronic pain patients include Lutetium Lu-177 dotatate and radiolabeled octreotide. Lutetium Lu-177 dotatate has shown significant treatment responses in neuroendocrine tumors and is FDA-approved for somatostatin-receptor positive tumors. Radiolabeled octreotide has demonstrated efficacy in various neuroendocrine malignancies, including metastatic medullary thyroid cancer.

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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.

Must not have

Participants with evidence of diffuse pain at the time of enrollment up to agent administration are to be excluded from this study.

Women who are pregnant or breastfeeding.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours post-scan

Awards & highlights

No Placebo-Only Group

Summary

This trial involves giving a small amount of a new drug called [11C]-NOP46 to people with long-term pain. The drug travels to the painful areas in the body, and a camera takes pictures of these areas. This could help doctors better understand and treat long-term pain.

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.

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.

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.

Select...

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

Select...

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

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have widespread pain currently.

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I am not pregnant or breastfeeding.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Uptake ratio for site with pain is >1

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for chronic pain work through various mechanisms. Pharmacologic treatments like NSAIDs and acetaminophen reduce inflammation and inhibit pain signals, while antidepressants and anticonvulsants modulate neurotransmitter levels to alleviate neuropathic pain. Psychological therapies, such as cognitive-behavioral therapy, help patients manage pain perception and improve coping strategies. Interventional approaches, including radiopharmaceuticals, target specific pain pathways and provide localized pain relief. Understanding these mechanisms is crucial for chronic pain patients as it allows for personalized treatment plans that can improve efficacy and reduce side effects. Radiotracers like [11C]-NOP46 used in PET/CT imaging help visualize pain pathways, aiding in the precise targeting of treatments.

Optimizing and Accelerating the Development of Precision Pain Treatments for Chronic Pain: IMMPACT Review and Recommendations.Challenges and opportunities in translational pain research - An opinion paper of the working group on translational pain research of the European pain federation (EFIC).Central Nervous System Targets: Supraspinal Mechanisms of Analgesia.