Nerve PainPhase 1NCT06599151
PETMRI for Chronic Pain from Spinal or Peripheral Nerve Origin
A Phase 1 study testing [18F]FTC-146 in people with Nerve Pain and Neuropathic Pain, run by Stanford University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nerve Pain, Neuropathic Pain, Nociceptive Pain
- What is being tested?
- [18F]FTC-146
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Oct 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Healthy Volunteers
- 1. At least 18 years old.
- Pain Subjects
- At least 18 years old.
- Chronic Pain is of Spinal or Peripheral Nerve Origin
- Subject's Chronic pain lasting greater than 2 months.
- Pain level of at least 4/10 on a 0-10 Comparative Pain Scale.
Who cannot join
- Healthy Volunteers
- Any chronic Pain
- Use of pain medication.
- MRI incompatibility.
- Kidney problems.
- Pregnant or nursing.
Show all 14Show fewer
- Non-English speaker.
- Presence of vasculopathy or Raynaud's.
- Inability to tolerate cessation of anticoagulant medication during the study.
- Pain Subjects
- MRI incompatibility.
- Kidney problems.
- Pregnant or nursing.
- Non-English speaker.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Neurosurgery Research Team contact
About this study
Official title: Use of (18F)FTC-146 PET_MRI for Characterizing Chronic Pain Phenotypes in Chronic Pain Patients with Spinal or Peripheral Nerve Origin
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:
Read more
- 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.
- To determine whether painful schwannomas can be differentiated from non-painful schwannomas based on imaging.
Secondary Objectives:
- To assess the reproducibility of [18F]FTC-146 PET imaging within the same healthy volunteer subjects using Test-Retest analysis.
- To investigate whether post-treatment [18F]FTC-146 uptake differs from pre-treatment uptake and correlate the imaging with subject reported pain level after treatment
Read the 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 on medical management and lost productivity1. Chronic pain can interfere with a person's daily life and lead to depression, insomnia and anxiety which can make the chronic pain worse. Chronic pain has many forms and appears across the body. For this study we will focus on chronic pain with spinal or peripheral nerve origin.
Chronic pain in the spinal cord or peripheral nerves can be caused by neuropathic pain, which occurs when the nervous system is damaged or malfunctions. Tumors, specifically schwannomas, are known to cause neuropathic chronic pain in subjects. The chronic pain can also be caused by nociceptive pain which is a type of pain that occurs when body tissue is damaged by physical or chemical agents, such as trauma, surgery, or chemical burns.
Pain is common and debilitating in people with schwannomatosis: Pain is the defining feature of most forms of schwannomatosis. While neurologic deficits (e.g., weakness) are relatively rare, pain is extremely common. Pain correlates with greater disability, and pain-related interference in daily activities correlates with poorer quality of life.
In patients with schwannomatosis, due to the presence of multiple tumors and frequent non-tumorigenic sources of pain, identifying the pain-generating tumor(s) can be difficult. This is particularly true since there does not seem to be any correlation between tumor size or active tumor growth and pain. Furthermore, even when pain can be localized to a specific nerve distribution, the nerve in question often will have multiple tumors along its course.
Current clinical methods for diagnosing and localizing pain generators are inadequate, highlighting the urgent need for more objective molecular assays capable of identifying sites of enhanced nociceptive activity. This will facilitate better diagnosis and targeted therapy for the patient. Additionally, the limited number availability of analgesic options for chronic and neuropathic pain patients, coupled with significant adverse effects, underscores the critical need for safer and better-tolerated analgesics.
- Being tested
- [18F]FTC-146
- Keywords
- PET/MRI, Chronic Pain, Nerve Pain
- Medical subject headings
- Neuralgia, Nociceptive Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FTC-146Drug
Adult participants will be injected with 5-10 mCi of [18F]FTC-146 and undergo a PET/MRI scan.
| Study group | Role | What they receive |
|---|---|---|
| Pain Patients With Spinal or Peripheral Nerve Origin | Experimental | Individuals suffering from nerve pain that is of spinal or peripheral nerve origin and undergo a [18F]FTC-146 PET/MRI scan. Receives: Drug: [18F]FTC-146 |
| Healthy Volunteers | Experimental | Individuals who do not have pain and undergo a [18F]FTC-146 PET/MRI scan. Receives: Drug: [18F]FTC-146 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodistribution of [18F]FTC-146- correlate with reported pain
Correlation of Standardized Uptake Value max (SUVmax) value with the participant's reported pain level
Measured: Estimated average of 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2030 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nerve PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All enrolled subjects (Pain Patients and Healthy Volunteers) will be injected with 5-10 mCi of \[18F\]FTC-146 and undergo a PET/MRI scan.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anand Veeravagu, Stanford University
- Investigators
- Anand Veeravagu, Principal investigator, Stanford University- Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599151
- Sponsor's protocol ID
- 76036
- Status last verified
- Sep 2024
- First submitted
- 21 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shen B, Behera D, James ML, Reyes ST, Andrews L, Cipriano PW, Klukinov M, Lutz AB, Mavlyutov T, Rosenberg J, Ruoho AE, McCurdy CR, Gambhir SS, Yeomans DC, Biswal S, Chin FT. Visualizing Nerve Injury in a Neuropathic Pain Model with [18F]FTC-146 PET/MRI. Theranostics. 2017 Jul 8;7(11):2794-2805. doi: 10.7150/thno.19378. eCollection 2017.
PubMed 28824716Shen B, Park JH, Hjornevik T, Cipriano PW, Yoon D, Gulaka PK, Holly D, Behera D, Avery BA, Gambhir SS, McCurdy CR, Biswal S, Chin FT. Radiosynthesis and First-In-Human PET/MRI Evaluation with Clinical-Grade [18F]FTC-146. Mol Imaging Biol. 2017 Oct;19(5):779-786. doi: 10.1007/s11307-017-1064-z.
PubMed 28280965James ML, Shen B, Nielsen CH, Behera D, Buckmaster CL, Mesangeau C, Zavaleta C, Vuppala PK, Jamalapuram S, Avery BA, Lyons DM, McCurdy CR, Biswal S, Gambhir SS, Chin FT. Evaluation of sigma-1 receptor radioligand 18F-FTC-146 in rats and squirrel monkeys using PET. J Nucl Med. 2014 Jan;55(1):147-53. doi: 10.2967/jnumed.113.120261. Epub 2013 Dec 12.
PubMed 24337599Entrena JM, Cobos EJ, Nieto FR, Cendan CM, Baeyens JM, Del Pozo E. Antagonism by haloperidol and its metabolites of mechanical hypersensitivity induced by intraplantar capsaicin in mice: role of sigma-1 receptors. Psychopharmacology (Berl). 2009 Jul;205(1):21-33. doi: 10.1007/s00213-009-1513-8. Epub 2009 Mar 27.
PubMed 19326101
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of (18F)FTC-146 PET_MRI for Characterizing Chronic Pain Phenotypes in Chronic Pain Patients with Spinal or Peripheral Nerve Origin
- ClinicalTrials.gov ID
- NCT06599151
- Acronym / sponsor ID
- 76036
- Keywords
- PET/MRI, Chronic Pain, Nerve Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2030 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- To determine whether painful schwannomas can be differentiated from non-painful schwannomas based on imaging.
Secondary Objectives:
- To assess the reproducibility of [18F]FTC-146 PET imaging within the same healthy volunteer subjects using Test-Retest analysis.
- To investigate whether post-treatment [18F]FTC-146 uptake differs from pre-treatment uptake and correlate the imaging with subject reported pain level after treatment
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 on medical management and lost productivity1. Chronic pain can interfere with a person's daily life and lead to depression, insomnia and anxiety which can make the chronic pain worse. Chronic pain has many forms and appears across the body. For this study we will focus on chronic pain with spinal or peripheral nerve origin.
Chronic pain in the spinal cord or peripheral nerves can be caused by neuropathic pain, which occurs when the nervous system is damaged or malfunctions. Tumors, specifically schwannomas, are known to cause neuropathic chronic pain in subjects. The chronic pain can also be caused by nociceptive pain which is a type of pain that occurs when body tissue is damaged by physical or chemical agents, such as trauma, surgery, or chemical burns.
Pain is common and debilitating in people with schwannomatosis: Pain is the defining feature of most forms of schwannomatosis. While neurologic deficits (e.g., weakness) are relatively rare, pain is extremely common. Pain correlates with greater disability, and pain-related interference in daily activities correlates with poorer quality of life.
In patients with schwannomatosis, due to the presence of multiple tumors and frequent non-tumorigenic sources of pain, identifying the pain-generating tumor(s) can be difficult. This is particularly true since there does not seem to be any correlation between tumor size or active tumor growth and pain. Furthermore, even when pain can be localized to a specific nerve distribution, the nerve in question often will have multiple tumors along its course.
Current clinical methods for diagnosing and localizing pain generators are inadequate, highlighting the urgent need for more objective molecular assays capable of identifying sites of enhanced nociceptive activity. This will facilitate better diagnosis and targeted therapy for the patient. Additionally, the limited number availability of analgesic options for chronic and neuropathic pain patients, coupled with significant adverse effects, underscores the critical need for safer and better-tolerated analgesics.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All enrolled subjects (Pain Patients and Healthy Volunteers) will be injected with 5-10 mCi of [18F]FTC-146 and undergo a PET/MRI scan.
| Arm | Type | Receives |
|---|---|---|
| Pain Patients With Spinal or Peripheral Nerve Origin | Experimental | Drug: [18F]FTC-146Individuals suffering from nerve pain that is of spinal or peripheral nerve origin and undergo a [18F]FTC-146 PET/MRI scan. |
| Healthy Volunteers | Experimental | Drug: [18F]FTC-146Individuals who do not have pain and undergo a [18F]FTC-146 PET/MRI scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy Volunteers
- 1. At least 18 years old.
- Pain Subjects
Key exclusion criteria (14 listed)
- Healthy Volunteers
- Pain Subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]FTC-146Adult participants will be injected with 5-10 mCi of [18F]FTC-146 and undergo a PET/MRI scan. | Drug | Healthy Volunteers, Pain Patients With Spinal or Peripheral Nerve Origin |
Primary outcome
Biodistribution of [18F]FTC-146- correlate with reported pain
Time frame: Estimated average of 4 hours
Correlation of Standardized Uptake Value max (SUVmax) value with the participant's reported pain level
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 28824716Shen B, Behera D, James ML, Reyes ST, Andrews L, Cipriano PW, Klukinov M, Lutz AB, Mavlyutov T, Rosenberg J, Ruoho AE, McCurdy CR, Gambhir SS, Yeomans DC, Biswal S, Chin FT. Visualizing Nerve Injury in a Neuropathic Pain Model with [18F]FTC-146 PET/MRI. Theranostics. 2017 Jul 8;7(11):2794-2805. doi: 10.7150/thno.19378. eCollection 2017.
- Background: PubMed 28280965Shen B, Park JH, Hjornevik T, Cipriano PW, Yoon D, Gulaka PK, Holly D, Behera D, Avery BA, Gambhir SS, McCurdy CR, Biswal S, Chin FT. Radiosynthesis and First-In-Human PET/MRI Evaluation with Clinical-Grade [18F]FTC-146. Mol Imaging Biol. 2017 Oct;19(5):779-786. doi: 10.1007/s11307-017-1064-z.
- Background: PubMed 24337599James ML, Shen B, Nielsen CH, Behera D, Buckmaster CL, Mesangeau C, Zavaleta C, Vuppala PK, Jamalapuram S, Avery BA, Lyons DM, McCurdy CR, Biswal S, Gambhir SS, Chin FT. Evaluation of sigma-1 receptor radioligand 18F-FTC-146 in rats and squirrel monkeys using PET. J Nucl Med. 2014 Jan;55(1):147-53. doi: 10.2967/jnumed.113.120261. Epub 2013 Dec 12.
- Background: PubMed 19326101Entrena JM, Cobos EJ, Nieto FR, Cendan CM, Baeyens JM, Del Pozo E. Antagonism by haloperidol and its metabolites of mechanical hypersensitivity induced by intraplantar capsaicin in mice: role of sigma-1 receptors. Psychopharmacology (Berl). 2009 Jul;205(1):21-33. doi: 10.1007/s00213-009-1513-8. Epub 2009 Mar 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neurosurgery Research Team contact
Anand Veeravagu principal investigator
Stanford University- Neurosurgery
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [18F]FTC-146 in people with Nerve Pain and Neuropathic Pain, run by Stanford University.
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 7 inclusion and 14 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: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adrian Valladarez ((650) 381-4257, adrian98@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodistribution of [18F]FTC-146- correlate with reported pain (time frame: Estimated average of 4 hours). 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 NCT06599151, 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 19 Sep 2024.