S1R Imaging-Based Cryoneurolysis in Chronic Pain

Early Phase 1Not Yet RecruitingNCT07768501

Davidzon, Guido, M.D.6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Pain Mixed Pain (Nociceptive and Neuropathic)

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Chronic nociceptive, neuropathic, or mixed pain for ≥2 months 2. Pain originating from a region amenable to cryoneurolysis (celiac plexus, intercostal nerves, pudendal nerve, peripheral nerve block 3. Chronic pain ≥2 months 4. Pain score ≥4/10 5. Pain location amenable to cryoneurolysis 6. Willing and able to provide consent. Exclusion Criteria: 1. Pregnancy or nursing. 2. Non-English speaking individuals 3. 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. 4. Weight \>350 pounds or a large body habitus, which the MR scanner cannot accommodate. 5. 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.

Outcomes

Primary Outcomes

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

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

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

Procedural Correlation

Degree of overlap between S1R treated focal uptake and clinical outcomes

Time frame: at 1 month post procedure