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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to understand chronic pain using a special scan called PET/MRI. The focus is on observing how the compound [18F]FTC-146, an experimental imaging agent, is absorbed in individuals with chronic pain compared to those without pain. This could help identify the source of pain and improve future treatment options. Individuals with chronic pain lasting more than two months and experiencing significant daily discomfort are suitable candidates for this trial. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new imaging agent.

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 prior data suggests that this method is safe for use in humans?

Research has shown that \[18F\]FTC-146 is safe for people. Studies have found that injections of \[18F\]FTC-146 are generally well-tolerated, with the body absorbing only small, acceptable amounts of radiation. This indicates it doesn't pose significant risks when used to identify sources of chronic pain. So far, no serious side effects have been reported in clinical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of [18F]FTC-146 in PET/MRI scans for chronic pain because it offers a novel way to visualize and understand pain pathways in the body. Unlike traditional treatments that focus on alleviating pain symptoms with medications like NSAIDs or opioids, [18F]FTC-146 targets the sigma-1 receptor, providing a unique imaging tool to explore pain mechanisms at a molecular level. This could lead to more precise diagnoses and personalized treatment plans, potentially transforming how chronic pain is managed.

What evidence suggests that this PET/MRI method is effective for identifying pain sources in chronic pain patients?

Research has shown that a special type of scan called [18F]FTC-146 PET/MRI can identify sources of chronic pain by targeting specific receptors in the body. One study discovered unexpected pain sources in 13 out of 15 patients, demonstrating its potential for accurate pain diagnosis. This trial will involve two groups: one of pain patients and the other of healthy volunteers. By comparing how [18F]FTC-146 is absorbed in individuals with and without chronic pain, researchers aim to understand pain development. This imaging method effectively reveals nerve injuries, which is crucial for managing and treating nerve-related pain. This could lead to improved methods for diagnosing and treating chronic pain in the future. ^{1 3 5 6 7}

Who Is on the Research Team?

Anand Veeravagu, MD

Principal Investigator

Stanford University Department of Neurosurgery

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03195270

NCT03195270 | Use of PET/MR Imaging in Chronic Pain One of the goals of the study is to determine whether [18F]FDG PET/MRI can identify sources of inflammation with greater sensitivity, accuracy and objectivity ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28824716/

Visualizing Nerve Injury in a Neuropathic Pain Model with ... In summary, [18F]FTC-146 S1R PET/MR imaging has the potential to impact how we diagnose, manage and treat patients with nerve injury, and thus ...

3. stanfordhealthcare.org stanfordhealthcare.org/trials/p/NCT03556137.html

PET/MRI in the Diagnosis of Chronic Pain The purpose of this study is to compare the uptake of \[18F\]FTC-146 in healthy volunteers to that of individuals suffering from chronic pain. Official Title.

4. jnm.snmjournals.org jnm.snmjournals.org/content/65/supplement_2/241818

Clinical Impact of Sigma-1 Receptor PET/MRI on Complex ... Results: Unexpected findings and potential pain sources were observed in 13 out of 15 patients through [18F]FTC-146 PET/MRI. These ...

5. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/1/NCT02753101.html

[18F]FTC-146 PET/MRI in Healthy Volunteers and in CRPS ... The researchers may potentially identify the source of pain generation in patients suffering from complex regional pain syndrome (CRPS) and chronic sciatica.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6944163/

Biodistribution and Radiation Dosimetry of 18F-FTC-146 in ... Injection of 18F-FTC-146 is safe, and absorbed doses are acceptable. The potential of 18F-FTC-146 as an imaging agent for chronic pain and neuroinflammatory ...

7. jnm.snmjournals.org jnm.snmjournals.org/content/jnumed/58/12/2004.full.pdf

Biodistribution and Radiation Dosimetry of 18F-FTC-146 in ... Injection of 18F-FTC-146 is safe, and absorbed doses are acceptable. The potential of 18F-FTC-146 as an imaging agent for chronic pain and ...