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Neuropathic PainPhase 1NCT03556137

PET/MRI in the Diagnosis of Chronic Pain

A Phase 1 study testing [18F]FTC-146 in people with Neuropathic Pain and Nociceptive Pain, run by Stanford University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Several studies have implicated involvement of sigma-1 receptors (SR1s) in the generation of chronic pain, while others are investigating anti SR1 drugs for treatment of chronic pain. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
[18F]FTC-146
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
1 siteUnited States
Study dates
16 Jul 2018to 31 Dec 2024
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

  • Healthy Volunteers:
  • At least 18 years old.
  • Covid Vaccination status: Vaccinated or unvaccinated subjects who received a negative test result from the Covid test within 72 hours of the scan.
  • Pain Patients:
  • At least 18 years old.
  • Chronic pain (nociceptive, neuropathic or mixed pain) lasting greater than 2 months.
  • 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

  • Healthy Volunteers:
  • Pain
  • Pain Medication
  • MRI incompatible
  • Pregnant or nursing
  • Non-English speaker
Show all 12Show fewer
  • Claustrophobic
  • Pain Patients:
  • MRI incompatible
  • Pregnant or nursing
  • Non-English speaker
  • Claustrophobic

Trial locations and contacts

1 site in 1 country.

Anand Veeravagu, MD contact

(650) 498-6154

anand.veeravagu@stanford.edu

Adrian Valladarez contact

adrian98@stanford.edu

United States1 site, 1 recruiting

  • Stanford University

    Stanford, California, 94305

    Adrian Valladarez, BA, adrian98@stanford.edu

    Anand Veeravagu, MD

    Recruiting

Other trials in United States

About this study

Official title: Use of [18F]FTC-146 PET/MRI in the Diagnosis of Chronic Pain

Several studies have implicated involvement of sigma-1 receptors (SR1s) in the generation of chronic pain, while others are investigating anti SR1 drugs for treatment of chronic pain. Using [18F]-FTC-146 and positron emission tomography/magnetic resonance imaging (PET/MRI), the investigators hope to identify the source of pain generation in patients with chronic pain. 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.

Read the detailed description

Chronic pain is a significant, widespread problem affecting every fifth person worldwide. Reported in 2011 by the Institute of Medicine, chronic pain affects 116 million American adults - more than the total number of individuals affected by heart disease, cancer, and diabetes combined. An estimated $635 billion each year is spent in the medical management of chronic pain and lost productivity. Better clinical methods to diagnose and localize pain are needed.

The investigators have developed a S1R-specific radiotracer, [18F]FTC-146. Using imaging approaches to assess the location of S1R in pain may provide a tool to diagnose pain generators, monitor treatment response, and aid in the selection of patients for treatment.

The goal is to use [18F]FTC-146 to image S1R expression in healthy volunteers and to compare the images to those individuals suffering from pain conditions in the following categories: (1) nociceptive pain (pain that results from tissue injury or inflammation), (2) neuropathic pain (pain that results from direct injury, disruption, impingement/compression or malfunction of the peripheral and/or central nervous system), and (3) mixed pain (pain that appears to have both nociceptive and neuropathic).

Being tested
[18F]FTC-146
Keywords
PET/MRI, Chronic Pain
Medical subject headings
Neuralgia, Nociceptive Pain, Radiculopathy, Spinal Cord Diseases, Chronic Pain

What participants receive

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

  • [18F]FTC-146Drug

    Also called S1R

    Adult participants will be injected with 5-10 mCi of [18F]FTC-146 and undergo a PET/MRI scan.

Study groups in NCT03556137
Study groupRoleWhat they receive
Pain PatientsExperimentalIndividuals suffering from nociceptive pain, neuropathic pain, and mixed pain (pain that appears to be both nociceptive and neuropathic) and undergo a [18F]FTC-146 PET/MRI scan.
Receives: Drug: [18F]FTC-146
Healthy VolunteersExperimentalIndividuals 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.

  1. [18F]FTC-146 Biodistribution in Healthy Volunteers

    Biodistribution of [18F]FTC-146 represented as Standardized Uptake Value max (SUVmax) in healthy volunteers.

    Measured: Estimated average of 3 hours

  2. [18F]FTC-146 Biodistribution in Pain Patients

    Biodistribution of [18F]FTC-146 represented as Standardized Uptake Value max (SUVmax) in pain patients.

    Measured: Estimated average of 3 hours

Timeline

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

  1. First posted14 Jun 2018
  2. Study start16 Jul 2018
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
190 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03556137
Sponsor's protocol ID
45332
Status last verified
Jul 2023
First submitted
2 Jun 2018
Last updated
20 Jul 2023
Results posted
No
Data monitoring committee
Yes
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 28824716

  • Hjornevik T, Cipriano PW, Shen B, Park JH, Gulaka P, Holley D, Gandhi H, Yoon D, Mittra ES, Zaharchuk G, Gambhir SS, McCurdy CR, Chin FT, Biswal S. Biodistribution and Radiation Dosimetry of 18F-FTC-146 in Humans. J Nucl Med. 2017 Dec;58(12):2004-2009. doi: 10.2967/jnumed.117.192641. Epub 2017 Jun 1.

    PubMed 28572487

  • Shen 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 28280965

  • Shen B, James ML, Andrews L, Lau C, Chen S, Palner M, Miao Z, Arksey NC, Shuhendler AJ, Scatliffe S, Kaneshige K, Parsons SM, McCurdy CR, Salehi A, Gambhir SS, Chin FT. Further validation to support clinical translation of [(18)F]FTC-146 for imaging sigma-1 receptors. EJNMMI Res. 2015 Dec;5(1):49. doi: 10.1186/s13550-015-0122-2. Epub 2015 Sep 17.

    PubMed 26384292

  • James 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 24337599

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [18F]FTC-146 in people with Neuropathic Pain and Nociceptive 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 8 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 20 Jul 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?

Results are not available in the source record.

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

Contact Anand Veeravagu, MD ((650) 498-6154, anand.veeravagu@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

[18F]FTC-146 Biodistribution in Healthy Volunteers (time frame: Estimated average of 3 hours). The study lists 2 primary outcomes in all. 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 NCT03556137, which also lists 6 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 20 Jul 2023.

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