Clinical trial NCT03556137: PET/MRI in the Diagnosis of Chronic Pain
Official title: Use of [18F]FTC-146 PET/MRI in the Diagnosis of Chronic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Neuropathic Pain
Nociceptive Pain
Mixed Pain (Nociceptive and Neuropathic)
Spinal Pain
Radiculopathy
Myelopathy
Neurogenic Claudication
Keywords: PET/MRI
Chronic Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2018-06-14
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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. 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.

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).

Eligibility criteria: Inclusion Criteria:

Healthy Volunteers:

1. At least 18 years old.
2. 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:

1. At least 18 years old.
2. Chronic pain (nociceptive, neuropathic or mixed pain) lasting greater than 2 months.
3. Pain level of at least 4/10 on a 0-10 Comparative Pain Scale.
4. Covid Vaccination status: Vaccinated or unvaccinated subjects who received a negative test result from the Covid test within 72 hours of the scan.

Exclusion Criteria:

Healthy Volunteers:

1. Pain
2. Pain Medication
3. MRI incompatible
4. Pregnant or nursing
5. Non-English speaker
6. Claustrophobic

Pain Patients:

1. MRI incompatible
2. Pregnant or nursing
3. Non-English speaker
4. Claustrophobic

Primary outcomes:
measure: [18F]FTC-146 Biodistribution in Healthy Volunteers
timeFrame: Estimated average of 3 hours
measure: [18F]FTC-146 Biodistribution in Pain Patients
timeFrame: Estimated average of 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University Department of Neurosurgery
name: Anand Veeravagu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.