Chronic PainEarly Phase 1NCT07768501
S1R Imaging-Based Cryoneurolysis in Chronic Pain
A Early Phase 1 study testing [18F]-FTC-146 in people with Chronic Pain and Mixed Pain (Nociceptive and Neuropathic), run by Davidzon, Guido, M.D..
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Mixed Pain (Nociceptive and Neuropathic)
- What is being tested?
- [18F]-FTC-146
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2030
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Molecular Imaging-Based Cryoneurolysis: Targeting Upregulated Sigma-1 Receptor Positive Nerves 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.
- Being tested
- [18F]-FTC-146
- Keywords
- chronic pain, PET/MRI, cryoneurolysis
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]-FTC-146Drug
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 group | Role | What they receive |
|---|---|---|
| Experimental: [18F]-FTC-146 | Experimental | 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. Receives: Drug: [18F]-FTC-146 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores and Functional Interference (Pain Disability Index [PDI])
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.
Measured: Assessed at baseline (pre-procedure) and at 1, 3, 6, and 12 months following cryoneurolysis.
Secondary outcomes (3)
Pain medication
Change in overall pain medication usage pre and post intervention. Opioids will be measured in oral morphine equivalents
Measured: 1, 3, 6, 12 months
Imaging Correlation
Degree of overlap between S1R focal uptake and clinical dermatomal pain diagrams. Correlation of SUVmax with pain severity.
Measured: At time of imaging and clinical assessment prior to intervention
Procedural Correlation
Degree of overlap between S1R treated focal uptake and clinical outcomes
Measured: at 1 month post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Davidzon, Guido, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Interventional Radiology Foundation
- Responsible party
- Principal investigator, Lynne N Martin, Stanford University
- Investigators
- Lynne N Martin, MD, Principal investigator, Stanford School of Medicine, RadiologyKip E Guja, MD, PhD, Principal investigator, Stanford School of Medicine, Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768501
- Sponsor's protocol ID
- 87276
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No