S1R Imaging-Based Cryoneurolysis in Chronic Pain

Sponsor
Davidzon, Guido, M.D.
Study ID
NCT07768501
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Chronic Pain
  • Mixed Pain (Nociceptive and Neuropathic)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [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.

Study Details

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.

Key Dates

First listed
Aug 17, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2030

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: [18F]-FTC-146
    All participants will receive an injection of 5-10 mCi \[18F\]FTC-146 formulated in a sterile and pyrogen-free isotonic solution followed by PET/MRI to identify sites of increased sigma-1 receptor (S1R) activity suggestive of pain generating nerve irritation or injury. Eligible patients with clinical symptoms correlating to the site of abnormal uptake on \[18F\]FTC-146 PET/MRI will then undergo cross-sectional (+/- ultrasound) -guided nerve block of the S1R positive site. If a patient notices a significant improvement in pain (≥50%), percutaneous cryoneurolysis of the S1R-positive site will then be performed within 1-4 weeks of the initial nerve block.

Primary Outcome Measure

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. ]

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