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S1R Imaging-Based Cryoneurolysis in Chronic Pain

ConditionsChronic PainMixed Pain (Nociceptive and Neuropathic)
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDavidzon, Guido, M.D.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • [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.

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: Experimental: [18F]-FTC-146Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

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

Secondary outcomes

1

Pain medication

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

Time frame
1, 3, 6, 12 months
2

Imaging Correlation

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

Time frame
At time of imaging and clinical assessment prior to intervention
3

Procedural Correlation

Degree of overlap between S1R treated focal uptake and clinical outcomes

Time frame
at 1 month post procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Davidzon, Guido, M.D.

Lead sponsor

Stanford University

Sponsor institution

Society of Interventional Radiology Foundation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: