PET/MRI in the Diagnosis of Chronic Pain

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03556137
• Other study ID #: 45332
• Status: Recruiting
• Phase: Phase 1
• Start date: July 16, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Stanford University
• Contact: Anand Veeravagu, MD
• Phone: (650) 498-6154
• Email: anand.veeravagu[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Mixed Pain (Nociceptive and Neuropathic)
• Myelopathy
• Neuralgia
• Neurogenic Claudication
• Neuropathic Pain
• Nociceptive Pain
• Radiculopathy
• Spinal Cord Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	GE Healthcare

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[18F]FTC-146 Biodistribution in Healthy Volunteers	Biodistribution of [18F]FTC-146 represented as Standardized Uptake Value max (SUVmax) in healthy volunteers.	Estimated average of 3 hours
Primary	[18F]FTC-146 Biodistribution in Pain Patients	Biodistribution of [18F]FTC-146 represented as Standardized Uptake Value max (SUVmax) in pain patients.	Estimated average of 3 hours