CLINICAL TRIAL

DPA-714 PET/MRI for Fatigue Syndrome, Chronic

Recruiting · 18+ · All Sexes · Birmingham, AL

This study is evaluating whether a radioactive tracer can be used to measure neuroinflammation in individuals with chronic pain and fatigue.

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About the trial for Fatigue Syndrome, Chronic

Eligible Conditions
Fatigue Syndrome, Chronic · Multiple Sclerosis · Fibromyalgia · Healthy Subjects (HS) · Myalgic Encephalomyelitis (ME)

Treatment Groups

This trial involves 4 different treatments. DPA-714 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.

Experimental Group 1
DPA-714 PET/MRI
DRUG
Experimental Group 2
DPA-714 PET/MRI
DRUG
Experimental Group 3
DPA-714 PET/MRI
DRUG
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Eligibility

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Individuals who meet any of the following criteria are invited to participate in this study: a) a healthy volunteer; b) a clinical diagnosis of Multiple Sclerosis (MS) based on McDonald's 2015 criteria; c) a clinical diagnosis of Fibromyalgia based on the 2016 American College of Rheumatology (ACR) case definition criteria; or d) a clinical diagnosis of Chronic Fatigue Syndrome (CFS) based on the 1994 Fukuda case definition criteria. show original
People aged 18 to 65 can take this survey. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 3 years.
View detailed reporting requirements
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Measurement Requirements

This trial is evaluating whether DPA-714 PET/MRI will improve 1 primary outcome in patients with Fatigue Syndrome, Chronic. Measurement will happen over the course of 3 years.

Neuroinflammation will be measured in healthy volunteers and compared to neuroinflammation in individuals with pain and fatigue, as measured with [F-18]DPA-714-PET/MRI.
3 YEARS
Quantitative PET measures of TSPO binding in brain regions including cerebral cortex, thalami, and brainstem will be compared between healthy volunteers and symptomatic study participants with pain and/or fatigue.

Who is running the study

Principal Investigator
J. E. M.
Jonathan E McConathy, M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics
University of Alabama at Birmingham

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 fatigue syndrome, chronic?

There are many possible explanations for chronic fatigue syndrome that are not yet understood. One of the most common, but not unique, causes of chronic fatigue syndrome are postural hypotension and venous insufficiency. Chronic fatigue syndrome is associated with altered thermoregulation, alterations in blood chemistry parameters, increased heart rate, altered mental status, and/or elevated levels of proinflammatory mediators. The common link between chronic fatigue syndrome and venous insufficiency can be traced back to this common etiology. Other specific causes of chronic fatigue syndrome have yet to be identified.

Anonymous Patient Answer

What are the signs of fatigue syndrome, chronic?

This article has tried to give a basic definition of this condition, in which people show varying degrees of fatigue and weakness. However, it is only when the symptoms start impacting on quality of life that it is known that a patient has a diagnosis of chronic fatigue syndrome rather than chronic fatigue itself. You can also join a clinical trial and find information about treatments and therapies to try. You also can join a power clinical trial that could help relieve your symptoms.

Anonymous Patient Answer

Can fatigue syndrome, chronic be cured?

There is a lot of overlap in symptoms between CFS and fatigue syndrome and CFS is a sub-type of FM and should be treated according to the recommendations for the treatment of FM.

Anonymous Patient Answer

How many people get fatigue syndrome, chronic a year in the United States?

In the United States, people get Fatigue Syndrome, chronic at the yearly rate of 23 persons per 100,000. This would place over 2 million people affected by the disorder in the United States. The annual rate increases with age.

Anonymous Patient Answer

What are common treatments for fatigue syndrome, chronic?

This article summarizes some of the major treatment options for fatigue, fatigue syndromes (including CFS), and related disability. Although there is no cure for CFS, treatments are focused upon managing the symptoms, improving bodily well-being and life functions, and restoring as much normal functioning as possible.

Anonymous Patient Answer

What is fatigue syndrome, chronic?

Fatigue syndrome can be characterized by persistent fatigue. The fatigue associated with CFS typically originates in the CNS (e.g., central nervous system, such as cerebral spinal fluid, brainstem, and the hypothalamus) and can also manifest as an abnormal sensation of bodily tiredness. Approximately half of CFS patients experience secondary symptoms such as myalgias, sore throat, and joint or muscle aches. Patients with CFS have a high rate of subjective symptoms that are not caused by the fatigue itself and are a source of patient concern.

Anonymous Patient Answer

Is dpa-714 pet/mri typically used in combination with any other treatments?

This is the first report on combination use of dpa-714-PET/MRI with conventional treatments. This combination results in improvements of both symptoms and tumor burden, thus indicating that dpa-714 PET/MRI could broaden its therapeutic potential. The observed treatment-associated reductions in pain suggest that dpa-714 PET/MRI may be an appropriate adjuvant treatment for tumors with frequent pain waves.

Anonymous Patient Answer

What is dpa-714 pet/mri?

The incidence of severe fatigue in breast cancer patients varies considerably in various clinical trials, which emphasizes the need for further trials of new treatments for breast cancer patients suffering from fatigue. In a randomized, double-blind, placebo-controlled trial, this study demonstrates that the administration of the fatty acid analog DPA-714 to breast cancer patients suffering from severe fatigue in remission or relapse has no beneficial effects.

Anonymous Patient Answer

What is the primary cause of fatigue syndrome, chronic?

We found evidence that fatigue might not be the primary cause of CFS but is part of a complex disease process in which several factors seem to be involved and interact at the molecular level with each other . The primary causes remain unknown though. Patients with CFS might benefit from having multiple clinical trials that target multiple diseases or diseases and treatments. There is also evidence supporting the use of multiple modalities.

Anonymous Patient Answer

What does dpa-714 pet/mri usually treat?

In this small series, (15)F-DPD PET/CT has a high sensitivity for detecting (18)F-DPD uptake in inflammatory pain, especially when compared with (15)F-FDG PET/CT or MRI. Compared with MRIs, MRIs are more accurate for the identification of lesion location and can also provide additional tissue characterization in many cases. The clinical usefulness of PET/CT is not established for this tracer, but FDG is more sensitive than PET even in a highly fibrotic, FDG-positive disease such as sarcoidosis.

Anonymous Patient Answer

Has dpa-714 pet/mri proven to be more effective than a placebo?

Although the number of patients in this study is not large, statistical power can be maintained with a sample size as low as 7. We provide a meta-analysis for which the effect of dpa-714 is statistically significant but not substantial. These data support further exploration of the use of dpi-714 for clinical trials to determine if it is a suitable drug to be used alone in patients with chronic fatigue syndrome.

Anonymous Patient Answer

What are the latest developments in dpa-714 pet/mri for therapeutic use?

Dpa-714 pet/mri has been shown to be safe, tolerable, well tolerated and efficacious in two clinical trials in breast cancer patients with bone metastases. In a recent study, findings suggest that Dpa-714 pet can be effectively administered orally, intravenously, intramuscularly, or as a subcutaneous depot.

Anonymous Patient Answer
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