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Clinical Trial NCT06599151 for Nerve Pain, Neuropathic Pain, Nociceptive Pain, MIxed Pain (Nociceptive and Neuropathic) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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PETMRI for Chronic Pain from Spinal or Peripheral Nerve Origin Phase 1 200

Not yet recruiting
Clinical Trial NCT06599151 is designed to study Diagnostic for Nerve Pain, Neuropathic Pain, Nociceptive Pain, MIxed Pain (Nociceptive and Neuropathic). This Phase 1 interventional study is not yet recruiting. Enrollment is planned to begin on 1 October 2024 until the study accrues 200 participants. Led by Stanford University, this study is expected to complete by 1 October 2030. The latest data from ClinicalTrials.gov was last updated on 19 September 2024.
Brief Summary
The purpose of this study is to compare the uptake of \[18F\]FTC-146 in healthy volunteers to that of individuals suffering from chronic pain with Spinal or Peripheral Nerve Origin.

Primary Objectives:

A) To quantify the bio-distribution of \[18F\] FTC-146 uptake in subjects with Spinal or Peripheral Nerve Origin pain and compare it with healthy controls.

B) To determine whether painful schwannomas can be differen...

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Detailed Description
Chronic pain represents a significant and widespread problem affecting approximately one-fifth person of the global population. As reported by the Institute of Medicine in 2011, chronic pain impacts 116 million American adults, surpassing the combined prevalence of heart disease, cancer, and diabetes. The economic burden associated with chronic pain is staggering, with an estimated annual expenditure of $635 billion ...Show More
Official Title

Use of (18F)FTC-146 PET_MRI for Characterizing Chronic Pain Phenotypes in Chronic Pain Patients with Spinal or Peripheral Nerve Origin

Conditions
Nerve PainNeuropathic PainNociceptive PainMIxed Pain (Nociceptive and Neuropathic)
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • 76036
NCT ID Number
NCT06599151
Start Date (Actual)
2024-10-01
Last Update Posted
2024-09-19
Completion Date (Estimated)
2030-10-01
Enrollment (Estimated)
200
Study Type
Interventional
PHASE
Phase 1
Status
Not yet recruiting
Keywords
PET/MRI
Chronic Pain
Nerve Pain
Primary Purpose
Diagnostic
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPain Patients With Spinal or Peripheral Nerve Origin
Individuals suffering from nerve pain that is of spinal or peripheral nerve origin and undergo a \[18F\]FTC-146 PET/MRI scan.
[18F]FTC-146
Adult participants will be injected with 5-10 mCi of \[18F\]FTC-146 and undergo a PET/MRI scan.
ExperimentalHealthy Volunteers
Individuals who do not have pain and undergo a \[18F\]FTC-146 PET/MRI scan.
[18F]FTC-146
Adult participants will be injected with 5-10 mCi of \[18F\]FTC-146 and undergo a PET/MRI scan.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Biodistribution of [18F]FTC-146- correlate with reported pain
Correlation of Standardized Uptake Value max (SUVmax) value with the participant's reported pain level
Estimated average of 4 hours
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes

  • Healthy Volunteers

    1. At least 18 years old.

  • Pain Subjects

    1. At least 18 years old.
    2. Chronic Pain is of Spinal or Peripheral Nerve Origin
    3. Subject's Chronic pain lasting greater than 2 months.
    4. Pain level of at least 4/10 on a 0-10 Comparative Pain Scale.

  • Healthy Volunteers

    1. Any chronic Pain
    2. Use of pain medication.
    3. MRI incompatibility.
    4. Kidney problems.
    5. Pregnant or nursing.
    6. Non-English speaker.
    7. Presence of vasculopathy or Raynaud's.
    8. Inability to tolerate cessation of anticoagulant medication during the study.

  • Pain Subjects

    1. MRI incompatibility.
    2. Kidney problems.
    3. Pregnant or nursing.
    4. Non-English speaker.
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Study Responsible Party
Anand Veeravagu, Principal Investigator, M.D. Asst. Professor, Stanford University
Study Central Contact
Contact: Adrian Valladarez, (650) 381-4257, [email protected]
Contact: Neurosurgery Research Team, [email protected]
No location data.