Total Body PET/CT Imaging for Myofascial Pain

Overseen By Lorenzo Nardo, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of California, Davis

Disqualifiers: Cancer, Spine infection, Arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

53 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to measure myofascial pain using advanced imaging techniques. Researchers will employ total-body PET/CT scans to examine myofascial tissue function, focusing on metabolism and blood flow. Participants will undergo scans with two substances: 11C-butanol, an alcohol used in imaging, and 18F-FDG, a glucose-based imaging agent. These substances help highlight areas of interest in the body. The study seeks individuals with chronic low back pain lasting at least three months, experienced most days, along with specific muscle tightness. As an Early Phase 1 trial, this research aims to understand how these imaging techniques function in people, offering participants a chance to contribute to groundbreaking advancements in pain assessment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

What prior data suggests that Total Body PET/CT Imaging is safe for investigating myofascial pain?

A small initial study successfully used 11C-butanol to measure blood flow in the body, demonstrating its safe application in imaging. Although specific safety data for 11C-butanol is limited, safety sheets suggest it might cause minor side effects like dizziness or irritation. However, these effects are uncommon in medical imaging.

Research has shown that 18F-FDG is widely used in imaging and is generally well-tolerated. It effectively detects the body's activity related to pain, aiding in the understanding of pain conditions. Studies using 18F-FDG for imaging have reported no major safety concerns.

As this trial is in its earliest phase, it primarily focuses on safety and effectiveness. While much remains to be learned, the use of these compounds in medical imaging has generally been safe so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it uses advanced imaging techniques to better understand myofascial pain. Unlike typical diagnostic methods, which often rely on patient-reported symptoms and physical exams, this approach uses total-body PET/CT scans with 11C-butanol and 18F-FDG tracers. These tracers provide dynamic imaging of the entire body, potentially revealing underlying patterns of pain that aren't visible with standard techniques. By offering a more comprehensive view of the body's metabolic activity and blood flow, this method could lead to more accurate diagnoses and targeted treatment strategies for myofascial pain.

What evidence suggests that this trial's imaging techniques could be effective for investigating myofascial pain?

In this trial, participants will undergo imaging with both 18F-FDG PET/CT and 11C-butanol PET/CT scans. Studies have shown that 18F-FDG PET/CT can identify areas in the body linked to pain, potentially aiding in the treatment of myofascial pain. The substance used in this imaging, 18F-FDG, highlights how the body uses sugar and has been effective in detecting pain areas, particularly in the spine and nerves. Research on another substance, 11C-butanol, has shown it can track blood flow in the body, aiding in understanding tissue function related to pain. Using both 18F-FDG and 11C-butanol together in imaging could provide a clearer view of myofascial tissues. These findings suggest that these imaging methods might help in understanding and eventually treating myofascial pain. ^{6 7 8 9 10}

Who Is on the Research Team?

Lorenzo Nardo, MD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

Adults over 18 with chronic low back pain for the past 3 months, experiencing pain more than half of the days in the last six months. Participants must have a palpable muscle nodule or taut band and be able to lay still for scans after fasting. Exclusions include pregnant individuals, those over 240 kg, people with certain medical conditions like cancer or spine issues, and anyone who can't consent in English.

Inclusion Criteria

I have had chronic low back pain for the past 3 months, with pain on most days in the last 6 months.

Ability to understand and willingness to sign an informed consent form

Ability to adhere to the study visit schedule and all protocol requirements

Exclusion Criteria

Implants at or in the region of the sites of interest

Positive straight leg raise test

Fasting blood glucose level greater than 200 mg/dl before administration of 18F-FDG

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo dynamic 18F-FDG PET/CT and 11C-butanol PET/CT scans on the EXPLORER total-body PET/CT system

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 11C-butanol
• 18F-FDG

Trial Overview The trial is testing TB-PET/CT imaging using two tracers (11C-butanol and 18F-FDG) to identify biomarkers for myofascial pain by measuring tissue metabolism, perfusion, and fatty infiltration. Participants will undergo two separate scans on different occasions while fasting.

How Is the Trial Designed?

Group I: PET/CT scans Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

11C-n-Butanol, a radiotracer, was shown to clear rapidly from the bloodstream and its distribution closely followed cardiac output, indicating its potential for assessing blood flow in tissues.

In studies involving tumor transplants in rats, 11C-butanol effectively differentiated blood supply to tumors compared to muscle, demonstrating a strong correlation with established methods, making it a promising tool for evaluating tumor vascularity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

11C-butanol for imaging of the blood-flow distribution in tumor-bearing animals. Knapp, WH., Helus, F., Oberdorfer, F., et al.[2019]

The study evaluated [18F]fluoroacetate (FAC) as a potential alternative to [11C]acetate (ACT) for diagnosing hepatocellular carcinoma (HCC) in five patients, but found significant differences in biodistribution between the two tracers.

[18F]FAC did not show increased activity in HCC lesions that were avid for [11C]ACT, indicating that it may not be a suitable substitute for [11C]ACT in PET/CT evaluations of HCC in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[18F]fluoroacetate positron emission tomography for hepatocellular carcinoma and metastases: an alternative tracer for [11C]acetate? Ho, CL., Cheung, MK., Chen, S., et al.[2016]

In a study involving 6 patients with low back pain, dynamic [18F]-sodium fluoride PET/MR imaging showed a significant positive correlation between the uptake rate in facet joints and the level of clinical disability, indicating that higher uptake is associated with greater disability.

These findings suggest that [18F]-NaF PET imaging could be a valuable biomarker for assessing disability related to facetogenic low back pain, potentially aiding in diagnosis and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[18F]-Sodium Fluoride PET MR-Based Localization and Quantification of Bone Turnover as a Biomarker for Facet Joint-Induced Disability. Jenkins, NW., Talbott, JF., Shah, V., et al.[2018]

In a study involving 6 female patients with fibromyalgia and 2 healthy volunteers, it was found that patients had a significantly lower metabolic rate of glucose utilization in skeletal muscle, indicating a potential metabolic dysfunction associated with the condition.

The research utilized advanced imaging techniques (18F-FDG PET) and a hyperinsulinemic euglycemic clamp to ensure accurate measurements, revealing that fibromyalgia patients had increased glucose backflow into the bloodstream, which contributed to reduced glucose phosphorylation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Determination of regional rate of glucose metabolism in lumbar muscles in patients with generalized tendomyopathy using dynamic 18F-FDG PET]. Frey, LD., Locher, JT., Hrycaj, P., et al.[2016]

The study successfully simplified the synthesis of the PET radiopharmaceutical [(18)F]FEDAC, achieving high-quality clinical-grade batches with a decay-corrected radiochemical yield of up to 52%.

Acute toxicity tests in rats showed no harmful effects from a single dose of [(18)F]FEDAC over 14 days, indicating its safety for potential use in first-in-human studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficient radiosynthesis and non-clinical safety tests of the TSPO radioprobe [(18)F]FEDAC: Prerequisites for clinical application. Kawamura, K., Kumata, K., Takei, M., et al.[2018]

Skeletal muscle accumulates high levels of fatty acid ethyl esters (FAEE) after ethanol exposure, which may contribute to alcoholic myopathy, a common condition among alcoholics.

In a study involving male Wistar rats, those that were fasted for 1 day and treated with ethanol showed the highest levels of FAEE in their muscles, indicating that fasting may influence FAEE accumulation and potentially the risk of muscle damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The total body mass of fatty acid ethyl esters in skeletal muscles following ethanol exposure greatly exceeds that found in the liver and the heart. Salem, RO., Laposata, M., Rajendram, R., et al.[2013]

In a study involving 22 participants (12 pain-free controls and 12 individuals with low back pain), PET/CT imaging revealed that those with low back pain had higher levels of inflammation and microcalcification in their lumbar spine, suggesting these factors may contribute to their pain.

The use of AI-based quantification in analyzing PET/CT scans proved effective, indicating that this method could help identify nociceptive sources of low back pain and should be explored further.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET/CT imaging of spinal inflammation and microcalcification in patients with low back pain: A pilot study on the quantification by artificial intelligence-based segmentation. Piri, R., Nøddeskou-Fink, AH., Gerke, O., et al.[2022]

Imaging studies have shown that myofascial trigger points exhibit distinct biomechanical properties and blood flow patterns compared to healthy tissue, indicating a potential objective way to assess myofascial pain syndrome.

Ultrasound-based imaging methods are currently favored for evaluating myofascial pain syndrome due to their efficacy, cost-effectiveness, and ease of use, although more research is needed to improve diagnostic accuracy and reproducibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Myofascial Trigger Points via Imaging: A Systematic Review. Mazza, DF., Boutin, RD., Chaudhari, AJ.[2023]

In a study involving 20 patients with chronic knee osteoarthritis and 19 healthy individuals, lower levels of γ-aminobutyric acid (GABA) in the mid-anterior cingulate cortex were strongly correlated with higher pain intensity, suggesting that GABA may play a role in the severity of chronic pain.

The research indicates that GABAergic disinhibition in the mid-anterior cingulate cortex could be a mechanism contributing to the persistence of pain, independent of factors like depression or anxiety, highlighting its potential as a biomarker for chronic pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cingulate GABA levels inversely correlate with the intensity of ongoing chronic knee osteoarthritis pain. Reckziegel, D., Raschke, F., Cottam, WJ., et al.[2020]

Patients with low back pain (LBP) showed significantly higher metabolic activity in the thoracic spinal cord, as measured by 18F-FDG PET/CT, compared to those without LBP, particularly at spinal nerves T7 to T10.

This study suggests that 18F-FDG PET/CT could serve as a useful biomarker for identifying active pain-related regions in the spinal cord, potentially guiding targeted treatments for LBP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of nociceptive-related metabolic activity in the spinal cord of low back pain patients using 18F-FDG PET/CT. Zhou, X., Cipriano, P., Kim, B., et al.[2021]

Increased praepubic 18F-FDG uptake is common in patients with polymyalgia rheumatica (PMR), occurring in 26% of the 89 patients studied, and should be considered in differential diagnoses for rheumatic and malignant diseases.

Therapeutic intervention with steroids led to a complete reduction of praepubic 18F-FDG accumulation in all 15 patients who underwent follow-up scans, indicating that this imaging biomarker can effectively reflect treatment response in PMR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET/CT imaging in polymyalgia rheumatica: praepubic 18F-FDG uptake correlates with pectineus and adductor longus muscles enthesitis and with tenosynovitis. Rehak, Z., Sprlakova-Pukova, A., Bortlicek, Z., et al.[2019]

A new and efficient method for synthesizing [1-11C]butanol, a key agent for imaging regional cerebral blood flow, was developed, ensuring high radiochemical and chemical purity.

The final product is a sterile, pyrogen-free solution that meets the stringent United States Pharmacopeia (USP) <823> standards, indicating its safety and suitability for medical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthesis of [1-11C]Butanol via a facile solid phase extraction protocol. Waterhouse, NN., Kothari, PJ., Dooley, M., et al.[2020]

In a study involving 12 patients with fibromyalgia syndrome (FMS) and 7 healthy controls, positron emission tomography (PET) scans showed no significant differences in brain glucose metabolism between the two groups.

The normal FDG-PET results suggest that there may be a disconnect between blood flow and glucose metabolism in the brains of FMS patients, indicating that traditional imaging may not reveal underlying abnormalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positron emission tomography in patients with fibromyalgia syndrome and healthy controls. Yunus, MB., Young, CS., Saeed, SA., et al.[2016]

Citations

1. withpower.com withpower.com/trial/early-phase-1-myofascial-pain-syndromes-4-2023-47e57

Total Body PET/CT Imaging for Myofascial Pain What data supports the effectiveness of the drug 11C-butanol and 18F-FDG for treating myofascial pain? The research shows that 18F-FDG PET/CT imaging can ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37652544/

Total-Body Perfusion Imaging with [11C]-Butanol - PubMed This pilot study demonstrates the ability to obtain reproducible measurements of total-body perfusion using [ 11 C]-butanol.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05876858/explorer-total-body-pet-ct-imaging-for-myofascial-pain?id=532&slug=muscle-pain

EXPLORER Total Body PET/CT Imaging for Myofascial Pain Total body PET/CT can be used in the assessment of myofascial tissue dysfunction using both FDG and 11C-Butanol.

4. trials.arthritis.org trials.arthritis.org/trials/NCT05876858

EXPLORER Total Body PET/CT Imaging for Myofascial Pain The main objective of this study is to establish novel measures derived from Total-body-Positron Emission Tomography/Computed Tomography (TB-PET/CT) as ...

5. researchgate.net researchgate.net/publication/373580965_Total-Body_Perfusion_Imaging_with_11C-Butanol

Total-Body Perfusion Imaging with [11C]-Butanol The total median effective dose combining PET and CT components for the mCT and Quadra was 13.9 (IQR 12.4–15.7) and 10.5 (IQR 9.4–12.3) mSv ...

6. opcw.org opcw.org/sites/default/files/documents/ADM/PSB/Tender/71-36-3_butanol.pdf

Safety Data Sheet May cause respiratory irritation. May cause drowsiness or dizziness. Specific target organ toxicity - repeated exposure no data available. Aspiration hazard no ...

7. fishersci.com fishersci.com/store/msds?partNumber=AAL13171AU&productDescription=1-BUTANOL+99%25+1KML&vendorId=VN00024248&countryCode=US&language=en

SAFETY DATA SHEET Precautionary Statements. Prevention. Wash face, hands and any exposed skin thoroughly after handling. Do not eat, drink or smoke when using ...

8. sigmaaldrich.com sigmaaldrich.com/US/en/sds/sial/281549?srsltid=AfmBOorJ52YISnYhrXt5dpLEUY8mWuzV7G7DWwcfwVIj6bXvMLhsuWMS

SAFETY DATA SHEET OSHA: No component of this product present at levels greater than or equal to 0.1% is on OSHA's list of regulated carcinogens. Reproductive ...

9. fishersci.com fishersci.com/store/msds?partNumber=A4004&productDescription=1-BUTANOL+SPECTRANALYZE+CR+4L&vendorId=VN00033897&countryCode=US&language=en

1-Butanol (Spectranalyzed) Precautionary Statements. Prevention. Wash face, hands and any exposed skin thoroughly after handling. Do not eat, drink or smoke when using ...

10. jnm.snmjournals.org jnm.snmjournals.org/content/64/11/1831

Total-Body Perfusion Imaging with [ 11 C]-Butanol This pilot study demonstrates the ability to obtain reproducible measurements of total-body perfusion using [ 11 C]-butanol.