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Chronic PainPhase 1NCT03195270

Use of PET/MR Imaging in Chronic Pain

A Phase 1 study testing [18F]FDG and PET/MRI in people with Chronic Pain, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Chronic Pain
What is being tested?
[18F]FDG and PET/MRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteUnited States
Study dates
24 Nov 2014to 20 Jan 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 18 years or older.
  • Chronic pain lasting greater than 2 months. For example: Low back pain, sciatica, complex regional pain syndrome, peripheral nerve injury, fibromyalgia, neuropathy, osteoarthritis, cancer pain, persistent post-operative pain, and migraine.
  • Provides informed consent
  • On a typical day, pain level of at least 4/10 on a 0-10 Comparative Pain Scale
  • Covid Vaccination status: Vaccinated or unvaccinated subjects who received a negative test result from the Covid test within 72 hours of the scan.

Who cannot join

  • MRI-incompatible
  • Diabetes
  • Pregnant or nursing
  • Non-English speaker
  • Claustrophobic

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

Official title: Use of [18F]FDG PET/MRI in the Diagnosis of Pain Generators and/or Sites of Inflammation and to Monitor Treatment Effects in Patients With Chronic Pain

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.

Read the detailed description

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.

Conditions
Chronic Pain
Being tested
[18F]FDG, PET/MRI
Keywords
Positron emission tomography, Magnetic Resonance Imaging, PET/MRI, Fluorodeoxyglucose, FDG, Pain, Chronic Pain, Neuropathic Pain, Inflammatory Pain, Nociceptive Pain
Medical subject headings
Chronic Pain, Pain, Neuralgia, Nociceptive Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F]FDGDrug

    Also called [18F]Fluorodeoxyglucose

    10 mCi of [18F]FDG via the antecubital vein in a bolus injection

  • PET/MRIDevice

    Also called Positron emission tomography/magnetic resonance imaging

    PET/MRI hybrid scanner used as diagnostic device

Study groups in NCT03195270
Study groupRoleWhat they receive
Single ArmExperimental[18F]FDG PET/MRI
Receives: Drug: [18F]FDG; Device: PET/MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. [18F]FDG PET/MRI as a spatial biomarker for chronic pain

    Identification of structures with increased [18F]FDG uptake (SUVmax) corresponding to pain.

    Measured: 5 years

Secondary outcomes (4)

  1. [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.

    Measured: 5 years

  2. 36 point Study Short-Form Health Survey

    Patient-reported state of health.

    Measured: 5 years

  3. Oswestry Disability Index

    Measure of disability, quality of life.

    Measured: 5 years

  4. Visual Analog Scale

    A visual, semi-quantitative method for patient-derived self-assessment of pain intensity.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2017
  2. Study start24 Nov 2014
  3. Primary completion20 Jan 2022
  4. Study completion20 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03195270
Sponsor's protocol ID
IRB-24972
Status last verified
May 2023
First submitted
19 Jun 2017
Last updated
16 May 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: There is currently no plan to share the individual participant data with other researchers outside our group of researchers or referring physicians.

Publications

  • 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.

    PubMed 21764788

  • 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.

    PubMed 21311407

  • 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.

    PubMed 35295458

  • 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.

    PubMed 34718774

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [18F]FDG and PET/MRI in people with Chronic Pain, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

[18F]FDG PET/MRI as a spatial biomarker for chronic pain (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03195270, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.

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