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NCT Number: NCT07768501

S1R Imaging-Based Cryoneurolysis in Chronic Pain

The goal of this clinical trial is to determine whether a sigma-1 receptor PET/MRI scan can help identify the specific nerves responsible for chronic pain.

Researchers will use an investigational imaging agent called [18F]FTC-146 to look for signs of pain generating nerve irritation or injury that may not be visible on convention imaging tests.

Participants whose pain-generating nerve can be identified may undergo a diagnostic nerve block and, if successful, a standard clinical procedure called cryoneurolysis will be used to temporarily interrupt pain signals.

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Key information

Conditions

Chronic Pain Mixed Pain (Nociceptive and Neuropathic) Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic nociceptive, neuropathic, or mixed pain for ≥2 months
  • Pain originating from a region amenable to cryoneurolysis (celiac plexus, intercostal nerves, pudendal nerve, peripheral nerve block
  • Chronic pain ≥2 months
  • Pain score ≥4/10
  • Pain location amenable to cryoneurolysis
  • Willing and able to provide consent.

Exclusion criteria

  • Pregnancy or nursing.
  • Non-English speaking individuals
  • Contraindication to MRI scanning which includes, but is not limited to, incompatible metal or hardware including pacemakers, cochlear implants, and bullets near a critical organ.
  • Weight >350 pounds or a large body habitus, which the MR scanner cannot accommodate.
  • Claustrophobia or feeling that he or she will be unable to lie still in the scanner for a period of 2 hours or fit in the PET/MR scanner due to body size.

Treatment and study plan

[18F]-FTC-146

Drug

Participants will receive a single intravenous injection of up to 5-10 mCi of [18F] FTC-146 inside the PET/MRI scanner. They will undergo up to three (3) whole-body PET/MRI scans with possible additional focused scan of the painful area within 180 minutes post- injection.

Primary outcomes

  1. Pain Scores and Functional Interference (Pain Disability Index [PDI])

    Time frame: Assessed at baseline (pre-procedure) and at 1, 3, 6, and 12 months following cryoneurolysis.

    The Pain Score measures pain intensity on a numeric or visual scale, from 0 to 10. The Pain Disability Index (PDI) measures how much pain limits a person's daily life across seven functional areas, scoring impact from 0 to 10 for each category.

Secondary outcomes

  1. Pain medication

    Time frame: 1, 3, 6, 12 months

    Change in overall pain medication usage pre and post intervention. Opioids will be measured in oral morphine equivalents

  2. Imaging Correlation

    Time frame: At time of imaging and clinical assessment prior to intervention

    Degree of overlap between S1R focal uptake and clinical dermatomal pain diagrams. Correlation of SUVmax with pain severity.

  3. Procedural Correlation

    Time frame: at 1 month post procedure

    Degree of overlap between S1R treated focal uptake and clinical outcomes

Sponsors and collaborators

Lead sponsor

Davidzon, Guido, M.D.

Other

Collaborators

  • Society of Interventional Radiology Foundation

Registry information

Official study title

Molecular Imaging-Based Cryoneurolysis: Targeting Upregulated Sigma-1 Receptor Positive Nerves in Chronic Pain

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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