EXPLORER Total Body PET/CT Imaging for Myofascial Pain

NCT05876858 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: 18343901R61AT012187-01
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to establish novel measures derived from Total-body-Positron Emission Tomography/Computed Tomography (TB-PET/CT) as quantitative biomarkers for the investigation of myofascial pain. The TB-PET/CT assessed measures are those reflective of myofascial tissue metabolism, perfusion, and fatty infiltration.

Conditions

Myofascial Pain

Keywords

total body positron emission tomography

Outcome Measures

Primary Outcomes (2)

• HEAL outcome measure

  Our primary outcome measure is the NIH Helping to End Addiction Long-term (HEAL) measure: PEG (Pain, Enjoyment, General Activity) score, which quantitatively evaluates pain intensity and interference. This is a score from 0 to 10.

  This is a cross-sectional study and the PEG score will be evaluated at baseline on the day of the scans.

• Differentiate Myofascial tissues

  The primary outcome measure is the Standardized Uptake Value (SUV) derived from the Positron Emission Tomography scans. This is a unitless quantity.

  Baseline; Up to 30 minutes (30 min being the time to fil out questionnaires)

Study Arms (1)

PET/CT scans

EXPERIMENTAL

Each subject will undergo a dynamic 18F-FDG PET/CT scan and a dynamic 11C-butanol PET/CT scan on the EXPLORER total-body PET/CT system

Drug: 18F-FDG; Drug: 11C-butanol

Interventions

18F-FDG DRUG

Each subject will undergo a dynamic 18F-FDG PET/CT scan (this drug is FDA approved) and a dynamic 11C-butanol PET/CT scan (this drug is under an IND) on the EXPLORER total-body PET/CT system. The two scans will be performed on the same day or within a period of up to four weeks depending on subject, imaging agent and scanner availability. Subjects will be asked to complete the HEAL questionnaires before or after their PET/CT scan on each day.

PET/CT scans

11C-butanol DRUG

Each subject will undergo a dynamic 18F-FDG PET/CT scan (this drug is FDA approved) and a dynamic 11C-butanol PET/CT scan (this drug is under an IND) on the EXPLORER total-body PET/CT system. The two scans will be performed on the same day or within a period of up to four weeks depending on subject, imaging agent and scanner availability. Subjects will be asked to complete the HEAL questionnaires before or after their PET/CT scan on each day.

PET/CT scans

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and willingness to sign an informed consent form
• Ability to adhere to the study visit schedule and all protocol requirements.
• Men and women ≥18 years of age
• Current self-report of chronic low back pain (cLBP) which has persisted for the past 3 months AND has resulted in pain on \> 50% of days in the past 6 months
• At least one palpable nodule or taut band in paraspinal, quadratus lumborum, or gluteal muscles
• Reproduction of the patient's dominant pain with palpation of a muscle nodule or taut band
• Predominantly paramedian pain (may be uni-lateral or bi-lateral)
• Willing and able to lay motionless in a supine position on 2 different occasions:
• minutes 18F-FDG scan
• minutes 11C-Butanol Scan
• Willing and able to fast for at least 6 hours before and for the duration of the scan
• Willing to avoid strenuous exercise for 24 hours before the scan visit

You may not qualify if:

• No Primary Care Physician
• History of any cancer (except non-melanoma skin cancer)
• History of spine infection (discitis or osteomyelitis) or spine tumor
• History of ankylosing spondylitis, rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, or lupus or other connective tissue diseases.
• Confounding conditions that are known to be responsible for inducing pain
• Implants at or in the region of the sites of interest
• Diagnosis of any vertebral fracture in the last 6 months
• Cauda equina syndrome or lumbar radiculopathy with functional motor deficit (strength\<4/5 on manual motor testing)
• Spinal implants (including fixation hardware, spinal cord stimulator, intra-thecal pumps)
• Predominantly central pain
• Pain below the knee
• Positive straight leg raise test
• Symptomatic hip arthritis
• Fasting blood glucose level greater than 200 mg/dl before administration of 18F-FDG
• Self-reported history of dysphoria or anxiety in closed spaces

Sponsors & Collaborators

• University of California, Davis: lead
• National Institutes of Health (NIH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of California Davis Health

Sacramento, California, 95826, United States

Location

MeSH Terms

Interventions

Fluorodeoxyglucose F18

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Lorenzo Nardo, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will undergo two PET/CT scans with two different radiotracers. In addition, participants will complete questionnaires to establish the association of quantitative TB-PET/CT measures with the NIH Helping to End Addiction Long-term (HEAL) outcome measures

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 26, 2023
• Study Start: June 13, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)