[Zr-89]Oxine-labeled leukocytes PET/MRI for Fibromyalgia

Phase-Based Estimates
1
Effectiveness
1
Safety
UAB, Birmingham, AL
+4 More
[Zr-89]Oxine-labeled leukocytes PET/MRI - Drug
Eligibility
18+
All Sexes
Eligible conditions
Fibromyalgia

Study Summary

Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.

See full description

Eligible Conditions

  • Fibromyalgia
  • Multiple Sclerosis
  • Fatigue Syndrome, Chronic
  • Myalgic Encephalomyelitis (ME)
  • Healthy Subjects (HS)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether [Zr-89]Oxine-labeled leukocytes PET/MRI will improve 1 primary outcome in patients with Fibromyalgia. Measurement will happen over the course of 3 years.

3 years
Regional brain distribution of radiolabeled white blood cells

Trial Safety

Safety Estimate

1 of 3

Trial Design

4 Treatment Groups

No Control Group
Chronic Fatigue Syndrome

This trial requires 120 total participants across 4 different treatment groups

This trial involves 4 different treatments. [Zr-89]Oxine-labeled Leukocytes PET/MRI is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Chronic Fatigue Syndrome
Fibromyalgia
Multiple Sclerosis
Healthy Controls

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 years for reporting.

Who is running the study

Principal Investigator
J. E. M.
Jonathan E McConathy, PhD
University of Alabama at Birmingham

Closest Location

UAB - Birmingham, AL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
1.18 to 65 years of age 2.Healthy volunteer OR Clinical diagnosis of Multiple Sclerosis (MS) OR Meets 2016 American College of Rheumatology (ACR) case definition criteria for fibromyalgia OR Meets 1994 Fukuda case definition criteria for Chronic Fatigue Syndrome

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes healthy subjects (hs)?

Add answer

Healthy adult males of a wide range of ages could have similar levels of the same circulating markers of inflammatory load. Although there is some evidence confirming a specific role of circulating TNF-α and sCD14, other inflammatory molecules are likely to be involved in the complex pathophysiology of the condition.

Unverified Answer

How many people get healthy subjects (hs) a year in the United States?

Add answer

The incidence of the three chronic conditions studied (asyrachis, ischemic heart disease, and diabetes) among the population studied does not suggest any increase in incidence with age.

Unverified Answer

What are common treatments for healthy subjects (hs)?

Add answer

HN and IBD diagnoses were common in Hs but not in HS. HN and IBD were often treated in hospitals of the NHS in Hs but not in HS.

Unverified Answer

What is healthy subjects (hs)?

Add answer

Healthy subjects were recruited from the general population by the University of Southern Denmark (UniSyd) for a clinical study on age at menarche and cardiovascular disease. At the age of 59-63 years, 2610 healthy Danish women (1489 men, 741 women) participated in the study. The mean age at menarche was 13.3 ± 2.5 years. There were 449 women with a spontaneous miscarriage and 20 women who had a miscarriage because of medical reasons.

Unverified Answer

Can healthy subjects (hs) be cured?

Add answer

The present data refute the idea that there is a specific'maturation' period for which hs may or may not be susceptible, making them especially suitable for studies in which a variable-length test-retest period is typically not feasible. Furthermore, this study and the findings of the previous one suggest that a change in lifestyle and/or therapeutic intervention are less likely to induce remission in hs as opposed to patients with rheumatoid arthritis.

Unverified Answer

What are the signs of healthy subjects (hs)?

Add answer

Recent findings demonstrated that, compared with hs, hs had higher levels of ALDH1A1 and BDNF mRNA in brain and higher A-type adipocytokine concentrations and lower levels of BDNF protein in placenta.

Unverified Answer

Is [zr-89]oxine-labeled leukocytes pet/mri typically used in combination with any other treatments?

Add answer

Zr-89 oxine-labeled leukocytes in combination with MRI are not commonly used in PET/CT imaging. Zr-89 oxine-labeled leukocytes in combination with MRI are typically used to confirm [Zr-89]oxine-labeled leukocytes localizing to tumors, especially in the case of small, low-fertility/late-stage tumors.

Unverified Answer

Have there been any new discoveries for treating healthy subjects (hs)?

Add answer

Some drugs have been approved for the treatment of hs; however, in both clinical trials and clinical practice most hs are still treated only on the basis of recommendations by guidelines and meta-analyses.

Unverified Answer

What is the average age someone gets healthy subjects (hs)?

Add answer

[Of young and older healthy controls, the average age of 18 years old, or 47 years old, or 74 years old is the age of health controls.](https://www.hfea.gov.

Unverified Answer

What are the latest developments in [zr-89]oxine-labeled leukocytes pet/mri for therapeutic use?

Add answer

Zinc (Zn) in the form of Zr (Zn) oxide labeled leukocytes can provide a radiometer. Zr-Oxide labeled leukocytes allow the radiometry of blood cells regardless of gender, age and disease status compared with blood from healthy normal controls. Zn is considered indispensable for survival and health of cells, and Zr-Oxide has been used in biomedical research for over 35 years, therefore our research is relevant, at least, with other medical use as well.

Unverified Answer

Who should consider clinical trials for healthy subjects (hs)?

Add answer

Age >70 is no longer considered a risk factor for healthy subjects in clinical trials. Younger age groups (18-55 yrs) are increasingly targeted, and so are women older than 65 yrs. More efficient methods for identifying and accelerating healthy subjects into clinical trials are needed for this age group.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Fibromyalgia by sharing your contact details with the study coordinator.