PET/MRI with [18F]FTC-146 for Chronic Pain

Overseen By Adrian Valladarez

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Stanford University

Must not be taking: Pain medication

Disqualifiers: Pregnant, Nursing, Claustrophobic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

190 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, since pain patients are not excluded for taking pain medication, it seems you may continue your current medications.

What data supports the effectiveness of the drug [18F]FTC-146 for chronic pain?

Research shows that [18F]FTC-146 is a potent imaging agent for neuropathic pain, which means it can help visualize areas of pain in the body. This suggests it may be useful in understanding and potentially managing chronic pain. ^{1 2 3 4 5}

Is [18F]FTC-146 safe for use in humans?

In a study with ten healthy volunteers, [18F]FTC-146 was found to be safe, with no adverse reactions reported during PET/MRI examinations. ^{1 3 4 6 7}

How does the treatment with [18F]FTC-146 for chronic pain differ from other treatments?

The treatment using PET/MRI with [18F]FTC-146 for chronic pain is unique because it combines advanced imaging techniques to potentially identify specific brain activity and nerve involvement in pain perception, which could lead to more precise diagnosis and management compared to traditional self-reporting methods. ^{1 4 8 9 10}

What is the purpose of this trial?

This trial uses a special imaging dye and advanced scans to find out where chronic pain is coming from in the body. It includes people with different types of chronic pain and healthy volunteers. The dye helps highlight pain-related areas in the scans, aiding in better diagnosis and treatment.

Research Team

Anand Veeravagu, MD

Principal Investigator

Stanford University Department of Neurosurgery

Eligibility Criteria

This trial is for adults over 18, both healthy and those with chronic pain lasting more than 2 months. Participants can be vaccinated or unvaccinated but must test negative for Covid within 72 hours of the scan. People who are pregnant, nursing, claustrophobic, non-English speakers, on pain medication (healthy volunteers), or incompatible with MRI cannot join.

Inclusion Criteria

I have been experiencing chronic pain for more than 2 months.

I have been experiencing chronic pain for more than 2 months.

My pain level is at least 4 out of 10.

Exclusion Criteria

Healthy Volunteers: Pregnant or nursing

If you don't speak English, you cannot participate as a healthy volunteer.

I am a healthy volunteer experiencing pain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo a [18F]FTC-146 PET/MRI scan to assess S1R expression

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate adverse effects post-imaging

1 week

Treatment Details

Interventions

• [18F]FTC-146

Trial Overview [18F]FTC-146 and PET/MRI technology are being tested to identify the source of chronic pain by comparing its uptake in healthy individuals versus those with chronic pain. The study aims to understand how sigma-1 receptors contribute to chronic pain conditions.

Participant Groups

Group I: Pain Patients Experimental Treatment 1 Intervention

Individuals suffering from nociceptive pain, neuropathic pain, and mixed pain (pain that appears to be both nociceptive and neuropathic) and undergo a \[18F\]FTC-146 PET/MRI scan.

Group II: Healthy Volunteers Experimental Treatment 1 Intervention

Individuals who do not have pain and undergo a \[18F\]FTC-146 PET/MRI scan.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

GE Healthcare

Industry Sponsor

Trials

307

Recruited

634,000+

Fotis Vlachos

GE Healthcare

Chief Marketing Officer since 2024

PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania

Peter J. Arduini

GE Healthcare

Chief Executive Officer since 2022

MBA from Northwestern University, BSc in Marketing from Susquehanna University

Findings from Research

Patients with low back pain (LBP) showed significantly higher metabolic activity in the thoracic spinal cord, as measured by 18F-FDG PET/CT, compared to those without LBP, particularly at spinal nerves T7 to T10.

This study suggests that 18F-FDG PET/CT could serve as a useful biomarker for identifying active pain-related regions in the spinal cord, potentially guiding targeted treatments for LBP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of nociceptive-related metabolic activity in the spinal cord of low back pain patients using 18F-FDG PET/CT. Zhou, X., Cipriano, P., Kim, B., et al.[2021]

In a study involving 6 patients with low back pain, dynamic [18F]-sodium fluoride PET/MR imaging showed a significant positive correlation between the uptake rate in facet joints and the level of clinical disability, indicating that higher uptake is associated with greater disability.

These findings suggest that [18F]-NaF PET imaging could be a valuable biomarker for assessing disability related to facetogenic low back pain, potentially aiding in diagnosis and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[18F]-Sodium Fluoride PET MR-Based Localization and Quantification of Bone Turnover as a Biomarker for Facet Joint-Induced Disability. Jenkins, NW., Talbott, JF., Shah, V., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

(18)F-FDG PET/MRI can be used to identify injured peripheral nerves in a model of neuropathic pain. [2016]

2. Germany pubmed.ncbi.nlm.nih.gov

Detection of nociceptive-related metabolic activity in the spinal cord of low back pain patients using 18F-FDG PET/CT. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Improved protocol for the radiosynthesis of [18 F]FTC-146: A potent and selective sigma-1 receptor radioligand. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

[18F]-Sodium Fluoride PET MR-Based Localization and Quantification of Bone Turnover as a Biomarker for Facet Joint-Induced Disability. [2018]

5. France pubmed.ncbi.nlm.nih.gov

Development of a PET radioligand for α2δ-1 subunit of calcium channels for imaging neuropathic pain. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Biodistribution and Radiation Dosimetry of 18F-FTC-146 in Humans. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Functional MRI of the Reserpine-Induced Putative Rat Model of Fibromyalgia Reveals Discriminatory Patterns of Functional Augmentation to Acute Nociceptive Stimuli. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Novel Approaches in Molecular Imaging and Neuroimaging of Fibromyalgia. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Chronic Pain Using Magnetic Resonance (MR) Neuroimaging Approaches: What the Clinician Needs to Know. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Biomarkers for chronic pain and analgesia. Part 1: the need, reality, challenges, and solutions. [2022]