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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT05876858
Other study ID # 1834390
Secondary ID 1R61AT012187-01
Status Suspended
Phase Early Phase 1
First received
Last updated
Start date June 13, 2023
Est. completion date September 2026

Study information

Verified date July 2023
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective of this study is to establish novel measures derived from Total-body-Positron Emission Tomography/Computed Tomography (TB-PET/CT) as quantitative biomarkers for the investigation of myofascial pain. The TB-PET/CT assessed measures are those reflective of myofascial tissue metabolism, perfusion, and fatty infiltration.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
18F-FDG
Each subject will undergo a dynamic 18F-FDG PET/CT scan (this drug is FDA approved) and a dynamic 11C-butanol PET/CT scan (this drug is under an IND) on the EXPLORER total-body PET/CT system. The two scans will be performed on the same day or within a period of up to four weeks depending on subject, imaging agent and scanner availability. Subjects will be asked to complete the HEAL questionnaires before or after their PET/CT scan on each day.
11C-butanol
Each subject will undergo a dynamic 18F-FDG PET/CT scan (this drug is FDA approved) and a dynamic 11C-butanol PET/CT scan (this drug is under an IND) on the EXPLORER total-body PET/CT system. The two scans will be performed on the same day or within a period of up to four weeks depending on subject, imaging agent and scanner availability. Subjects will be asked to complete the HEAL questionnaires before or after their PET/CT scan on each day.

Locations

Country Name City State
United States University of California Davis Health Sacramento California

Sponsors (3)

Lead Sponsor Collaborator
University of California, Davis National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary HEAL outcome measure Our primary outcome measure is the NIH Helping to End Addiction Long-term (HEAL) measure: PEG (Pain, Enjoyment, General Activity) score, which quantitatively evaluates pain intensity and interference. This is a score from 0 to 10. This is a cross-sectional study and the PEG score will be evaluated at baseline on the day of the scans.
Primary Differentiate Myofascial tissues The primary outcome measure is the Standardized Uptake Value (SUV) derived from the Positron Emission Tomography scans. This is a unitless quantity. Baseline; Up to 30 minutes (30 min being the time to fil out questionnaires)
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