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?

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.

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.

Is 11C-butanol safe for use in humans?

11C-butanol has been used in studies to image blood flow in animals, and it was produced as a sterile, pyrogen-free solution meeting safety standards. However, specific human safety data is not provided in the available research. ^{1 2 3 4 5}

How does the treatment in the Total Body PET/CT Imaging for Myofascial Pain trial differ from other treatments for this condition?

This treatment is unique because it uses total body PET/CT imaging to detect metabolic activity related to pain, which can help identify specific areas of pain in the body. Unlike traditional treatments that focus on symptom relief, this approach aims to understand the underlying metabolic changes associated with myofascial pain. ^{6 7 8 9 10}

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 detect metabolic activity related to pain in the spinal cord, which may help in understanding pain conditions like myofascial pain. Additionally, 18F-FDG has been used to identify inflammation in low back pain, suggesting its potential usefulness in assessing pain-related conditions. ^{6 7 11 12 13}

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

I can fast for at least 6 hours before and during the scan.

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

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]

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]

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]

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]

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]

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 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]

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]

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]

Citations

1. United States 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. [2018]

2. Germany 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. [2021]

3. England 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Assessment of Myofascial Trigger Points via Imaging: A Systematic Review. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Cingulate GABA levels inversely correlate with the intensity of ongoing chronic knee osteoarthritis pain. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Efficient radiosynthesis and non-clinical safety tests of the TSPO radioprobe [(18)F]FEDAC: Prerequisites for clinical application. [2018]

7. England 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. [2013]

8. Germany pubmed.ncbi.nlm.nih.gov

11C-butanol for imaging of the blood-flow distribution in tumor-bearing animals. [2019]

9. England pubmed.ncbi.nlm.nih.gov

[18F]fluoroacetate positron emission tomography for hepatocellular carcinoma and metastases: an alternative tracer for [11C]acetate? [2016]

10. England pubmed.ncbi.nlm.nih.gov

Synthesis of [1-11C]Butanol via a facile solid phase extraction protocol. [2020]

11. Germany 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]. [2016]

12. United States pubmed.ncbi.nlm.nih.gov

Positron emission tomography in patients with fibromyalgia syndrome and healthy controls. [2016]

13. Poland 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. [2019]