Clinical Trial Details
— Status: Suspended
Administrative data
NCT number |
NCT05876858 |
Other study ID # |
1834390 |
Secondary ID |
1R61AT012187-01 |
Status |
Suspended |
Phase |
Early Phase 1
|
First received |
|
Last updated |
|
Start date |
June 13, 2023 |
Est. completion date |
September 2026 |
Study information
Verified date |
July 2023 |
Source |
University of California, Davis |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.