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EXPLORER Total Body PET/CT Imaging for Myofascial Pain

Primary Purpose

Myofascial Pain

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-FDG
11C-butanol
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Myofascial Pain focused on measuring total body positron emission tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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: 60-70 minutes 18F-FDG scan 10-20 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 Exclusion Criteria: 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 Pregnant or lactating subjects Body weight more than 240 kg (529 pounds) due to the weight limitation of the scanner bed Prisoners Inability to speak, read, and write in the English language Concurrent or prior enrollment in a separate research study involving a PET scan performed within the last 12 months for research purposes only Any other criteria, which would make the subject unsuitable to participate in this study as determined by the Principal Investigator (e.g., subject has a Legally Authorized Representative and cannot consent for him/herself)

Sites / Locations

  • University of California Davis HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET/CT scans

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 27, 2023
Last Updated
July 29, 2023
Sponsor
University of California, Davis
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT05876858
Brief Title
EXPLORER Total Body PET/CT Imaging for Myofascial Pain
Official Title
EXPLORER Total Body PET/CT Imaging for Myofascial Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Davis
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Myofascial pain syndrome (MPS) is a prevalent and debilitating condition representing a significant societal burden. It is a chronic muscular pain disorder involving one muscle or groups of muscles, which is frequently accompanied by decreased range of motion, weakness, autonomic phenomena, depression, anxiety, sleep disturbance, and altered mental function. MPS affects up to 85% of patients with chronic pain and it is one of the most frequent reasons for referral to large pain clinics. The highest age-specific incidence rate is in the early 20's while prevalence increases with age until the sixth decade of life. This specific epidemiology of the disease creates a large economic burden on society due to not only health-care related expense but, especially, due to disabilities and work absenteeism. Patients often receive treatment for myofascial pain, which are often neither standardized nor evidence-based. Treatment for myofascial pain consists of pharmacologic and nonpharmacologic interventions. Pharmacologic therapies include nonsteroidal anti-inflammatory drugs, muscle relaxants, benzodiazepines, and opioids. All these therapies have systemic physical side effects which can lead to severe chronic complications, especially when chronically prescribed. All of these are also known as being addictive or misused/overused. Non-pharmaceutical approaches ranging from non-invasive physical force-based manipulations to mini-invasive interventions such as acupuncture. These non-pharmacologic approaches are associated with minimal or negligible side effects and have been recently introduced into a conceptual model of integrative medicine. There are no validated biomarkers for qualitative or quantitative assessment of MPS, which can be used to guide clinical management. It is crucial to have a reliable biomarker to assess therapy or intervention response. While many approaches have been attempted with several different techniques including MRI and US, there has not been a solid effort to assess a functional/molecular biomarker with PET/CT. Conventional PET/CT scanners are affected by low signal efficiency collection and low spatial resolution, which have made them unpractical to develop MPS biomarkers. However, the first Total Body PET/CT (TB-PET/CT) was successful in imaging the whole body simultaneously (field of view of 194 cm), with low injected activity doses (1/20 of the regular dose) and reduced acquisition times (less than 1 minute). The Investigators conducted several first-in-human studies using the TB-PET/CT system in participants with cancer, autoimmune arthritis, Covid-19, neurodegeneration and HIV. This included imaging the entire body down to a single nail of the finger. These strong data clearly address challenges of current PET/CT systems, such as their inability to assess the entire body in the same phase of radiotracer uptake, long scan times resulting from sequential acquisitions of the entire body that may not be well-tolerated by patients, significant ionizing radiation exposure in the context of monitoring chronic disease activity in a longitudinal setting, and limited PET spatial resolution for measuring radiotracer uptake in small lesions. Therefore, TB-PET/CT is poised to shift the paradigm in a range of research areas towards utilizing of advanced imaging technology. The PET radiotracer Fluorodeoxyglucose (18F-FDG) is a marker of glucose metabolism and is the mostly common radiotracer used in the PET imaging field. This radiotracer is FDA approved. 11C-Butanol is a marker for blood perfusion. This radiotracer is not FDA approved, and it will be used under an IND for this study. In summary, these observations support our overall scientific premise that total body PET/CT can be used in the assessment of myofascial tissue dysfunction using both FDG and 11C-Butanol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain
Keywords
total body positron emission tomography

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PET/CT scans
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
18F-FDG
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
11C-butanol
Intervention Description
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.
Primary Outcome Measure Information:
Title
HEAL outcome measure
Description
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.
Time Frame
This is a cross-sectional study and the PEG score will be evaluated at baseline on the day of the scans.
Title
Differentiate Myofascial tissues
Description
The primary outcome measure is the Standardized Uptake Value (SUV) derived from the Positron Emission Tomography scans. This is a unitless quantity.
Time Frame
Baseline; Up to 30 minutes (30 min being the time to fil out questionnaires)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: 60-70 minutes 18F-FDG scan 10-20 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 Exclusion Criteria: 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 Pregnant or lactating subjects Body weight more than 240 kg (529 pounds) due to the weight limitation of the scanner bed Prisoners Inability to speak, read, and write in the English language Concurrent or prior enrollment in a separate research study involving a PET scan performed within the last 12 months for research purposes only Any other criteria, which would make the subject unsuitable to participate in this study as determined by the Principal Investigator (e.g., subject has a Legally Authorized Representative and cannot consent for him/herself)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lynda Painting, BS
Phone
916-731-9004
Email
lpainting@ucdavis.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dana Little, MS
Phone
916-734-7749
Email
dalittle@ucdavis.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorenzo Nardo, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95826
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynda Painting
Phone
916-731-9004
Email
lpainting@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Dana Little, MS
Phone
916-734-7749
Email
dalittle@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Lorenzo Nardo, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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EXPLORER Total Body PET/CT Imaging for Myofascial Pain

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