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| Name | Class |
|---|---|
| GE Healthcare | INDUSTRY |
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The investigators are studying the ability of PET/MR imaging (using the PET tracer [18F]FDG) to objectively identify and characterize pain generators in patients suffering from chronic pain.
The diagnosis and management of chronic and neuropathic pain syndromes remains a major clinical challenge, and this failure is partly attributed to our inability to identify the hypersensitive and inflammatory changes in the pain-sensing part of our nervous system that is thought to contribute to these syndromes. The lack of a specific, objective diagnostic test for chronic and neuropathic pain syndromes can result in a delay of diagnosis and suboptimal management decisions. This delay in diagnosis is quite unfortunate since the early diagnosis and treatment of a disease is attributed to the highest probability of remission in certain chronic pain syndromes. Additionally, identifying the correct source of pain is of paramount importance since the clinical course and therapeutic interventions are different depending on cause.
Evidence in the literature points strongly toward an active inflammatory component in chronic pain. For example, soft tissue and bony inflammation is known to be an important pathophysiological mechanism for the symptoms of certain neuropathic pain syndromes. Similarly, individuals suffering from chronic sciatica or radiculopathy may suffer from a combination of inflammation and compression of lumbar or cervical spinal nerves. It is also established that inflammatory lesions have increased metabolism and energy requirements and, therefore, are more glucose-avid than normal tissues, showing increased uptake of radiolabeled glucose analogs, such as [18F]fluorodeoxyglucose ([18F]FDG). Correspondingly, [18F]FDG positron emission tomography-magnetic resonance imaging (PET/MRI) represent leading FDA-approved clinical imaging modalities to longitudinally study metabolic changes in the nervous system and non-neural tissues (e.g., muscle, blood vessels, joints, bone, scar tissue, etc.) in patients with chronic pain conditions. One of the goals of the study is to determine whether [18F]FDG PET/MRI can identify sources of inflammation with greater sensitivity, accuracy and objectivity than current diagnostic methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | [18F]FDG PET/MRI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]FDG | Drug | 10 mCi of [18F]FDG via the antecubital vein in a bolus injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| [18F]FDG PET/MRI as a spatial biomarker for chronic pain | Identification of structures with increased [18F]FDG uptake (SUVmax) corresponding to pain. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| [18F]FDG Biodistribution in Healthy Subjects | We will use PET/MRI to establish the normal range of [18F]FDG uptake. (SUVmax) in various anatomic structures, such as the spinal cord, peripheral nerves, dorsal root ganglia, muscle, bones, joints, blood vessels, of asymptomatic subjects. | 5 years |
| 36 point Study Short-Form Health Survey |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Feliks Kogan, PhD | Assistant Professor of Radiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21764788 | Background | Behera D, Jacobs KE, Behera S, Rosenberg J, Biswal S. (18)F-FDG PET/MRI can be used to identify injured peripheral nerves in a model of neuropathic pain. J Nucl Med. 2011 Aug;52(8):1308-12. doi: 10.2967/jnumed.110.084731. Epub 2011 Jul 15. | |
| 21311407 | Background | Do BH, Mari C, Tseng JR, Quon A, Rosenberg J, Biswal S. Pattern of 18F-FDG uptake in the spinal cord in patients with non-central nervous system malignancy. Spine (Phila Pa 1976). 2011 Oct 1;36(21):E1395-401. doi: 10.1097/BRS.0b013e31820a7df8. |
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There is currently no plan to share the individual participant data with other researchers outside our group of researchers or referring physicians.
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D010146 | Pain |
| D009437 | Neuralgia |
| D059226 | Nociceptive Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
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| ID | Term |
|---|---|
| D019788 | Fluorodeoxyglucose F18 |
| D049268 | Positron-Emission Tomography |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D014055 | Tomography, Emission-Computed |
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Participants will be recruited based on established criteria for chronic pain. For the PET/MRI scan, the participants will be injected with 10 mCi±1 mCi of [18F]FTC-146 via the antecubital vein in a bolus injection. PET and MRI scans will be acquired simultaneously using a hybrid PET/MRI scanner. Following the scan, participants will be contacted to check for adverse drug events, and any events will be recorded in the case report. The biodistribution of radiotracer will be analyzed using regions of interest (ROI) marked on anatomical structures on magnetic resonance images and quantifying the signal in PET images within the same ROIs. Pharmacokinetic information will be derived using mathematical modeling. Data from chronic pain patients will be compared to historical data from asymptomatic controls.
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| PET/MRI | Device | PET/MRI hybrid scanner used as diagnostic device |
|
|
Patient-reported state of health. |
| 5 years |
| Oswestry Disability Index | Measure of disability, quality of life. | 5 years |
| Visual Analog Scale | A visual, semi-quantitative method for patient-derived self-assessment of pain intensity. | 5 years |
| 35295458 | Derived | Yoon D, Fast AM, Cipriano P, Shen B, Castillo JB, McCurdy CR, Mari Aparici C, Lum D, Biswal S. Sigma-1 Receptor Changes Observed in Chronic Pelvic Pain Patients: A Pilot PET/MRI Study. Front Pain Res (Lausanne). 2021 Oct 20;2:711748. doi: 10.3389/fpain.2021.711748. eCollection 2021. |
| 34718774 | Derived | Yoon D, Xu Y, Cipriano PW, Alam IS, Mari Aparici C, Tawfik VL, Curtin CM, Carroll IR, Biswal S. Neurovascular, Muscle, and Skin Changes on [18F]FDG PET/MRI in Complex Regional Pain Syndrome of the Foot: A Prospective Clinical Study. Pain Med. 2022 Feb 1;23(2):339-346. doi: 10.1093/pm/pnab315. |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D007090 |
| Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |