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Looking for signs of inflammation in the brain of Chronic Fatigue Syndrome Patients


- candidate number23604
- NTR NumberNTR5642
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-jan-2016
- Secondary IDsEudraCT: 2014-004448-37 
- Public TitleLooking for signs of inflammation in the brain of Chronic Fatigue Syndrome Patients
- Scientific TitleVisualising Neuroinflammation in Chronic Fatigue Syndrome Patients
- ACRONYMPET-CFS-1
- hypothesisInvestigate if Chronic Fatigue Syndrome patients show signs of neuroinflammation, compared to Q-fever Fatigue Syndrome (QFS) patients and healthy neighbourhood controls.
- Healt Condition(s) or Problem(s) studiedChronic Fatigue Syndrome (CFS)
- Inclusion criteriaControl subjects:
- Female, between 18 and 60 years old;
- Healthy age- and sexe-matched controls, i.e. live in the same neighbourhood as the Chronic Fatigue Syndrome patient

Chronic Fatigue Syndrome (CFS) patients:
- CDC-diagnosed CFS-patients;
- Female, between 18 and 60 years old;
- Score of 40 on the subscale fatigue severity of the CIS (Checklist Individual Strength);
- Marked functional impairment assessed with the Sickness Impact Profile (SIP-8) and operationalised as a total score of 700.
- Exclusion criteriaAll subjects:
- Women who are pregnant;
- Women who intend to get pregnant during the study;
- Use or having used psychotropic medication in the past six months;
- Alcohol or substance abuse in the past 3 months;
- Evident somatic/psychiatric co-morbidity;
- Presence of materials in the body that can be magnetized and cannot be removed;
- Participation in a scientific research study during the past year involving radiation.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-mrt-2016
- planned closingdate1-mrt-2017
- Target number of participants20
- Interventions[11C]PK11195 (a ligand for the TSPO protein, upregulated in activated microglia cells) is injected in both patients, and healthy age- and sexe-matched controls. Binding of this tracer will be visualised on PET scan, indicating degree of neuroinflammation (activated microglia cells).
- Primary outcomeThe primary objective of this study is to evaluate whether there is an increased binding potential of the TSPO ligand [11C]PK11195, which is a marker for microglia activation in neuroinflammation, using PET in patients with chronic fatigue syndrome compared to healthy age- and sexe-matched controls.
- Secondary outcome- To correlate the binding potential of [11C]PK11195 to MRI measurements in the same patients (for example grey matter reduction).
- To correlate binding potential of [11C]PK11195 to fatigue severity using the CIS fatigue questionnaire.
- To correlate binding potential of [11C]PK11195 expression to peripheral cytokine concentrations.
- TimepointsThere is one timepoint on which all measurements will be conducted.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc Ruud Raijmakers
- CONTACT for SCIENTIFIC QUERIESMSc Ruud Raijmakers
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summaryRationale: Chronic Fatigue Syndrome (CFS) is a disease of unknown origin characterized by the presence of severe disabling fatigue for a period of at least six months. Patients often are diagnosed after having symptoms for several years, as there is no accurate diagnostic tool to diagnose CFS. This leads to a delay in starting treatment.

Q Fever fatigue syndrome (QFS) is a well documented state of prolonged fatigue following acute Q fever, an infection caused by Coxiella burnetii. Up to 20% of patients diagnosed with acute Q fever will eventually develop QFS, leading to a substantial burden for those who are affected. The clinical presentation of QFS sometimes shows overlapping symptoms with the symptoms of CFS patients. As is the case with CFS, research is still focused on finding better tools for diagnosing and treating this disease.

To improve diagnosis and treatment it is important to understand the mechanisms underlying these diseases. It has been proposed that (neuro)inflammation is an important factor in the development of CFS. We therefore aim to assess whether CFS and QFS are accompanied by the presence of neuroinflammation, using Positron Emission Tomography (PET).

Objective: The primary objective of this study is to evaluate whether there is an increased binding potential of the TSPO ligand [11C]PK11195, which is a marker for microglia activation in neuroinflammation, using PET in patients with CFS compared to patients with QFS and healthy age- and sexe-matched controls. Secondary objective(s) are to correlate the binding potential of [11C]PK11195 to (1) MRI measurements in the same subjects, (2) to fatigue severity using the CIS fatigue questionnaire and (3) to peripheral cytokine concentrations.

Study design: The design of this study is observational and case control, comparing the presence of neuroinflammation between CFS patients, QFS patients and healthy age- and sexe-matched controls.

Study population: The study population will consist of 10 CFS patients, 10 QFS patients and 10 healthy age- and sexe-matched controls subjects, which are neighbourhood controls. All subjects are females with an age between 18 and 60 years old.

Intervention: The subjects will undergo a PET scan with the TSPO ligand [11C]PK11195, which is a marker for microglia activation in neuroinflammation.

Main study parameters/endpoints: The main study parameter is the [11C]PK11195 binding potential in the brain.
- Main changes (audit trail)25-nov-2016: Amendment: addition 10 Q-fever patients in trial.

Inclusion NEW:
Q-fever Fatigue Syndrome (QFS) patients
-Diagnosis according to the Dutch guideline on QFS [RIVM, Q-koortsvermoeidheidssyndroom];
-Female, between 18 and 60 years old;
-Score of ≥40 on the subscale fatigue severity of the CIS (Checklist Individual Strength);
-Marked functional impairment assessed with the Sickness Impact Profile (SIP-8) and operationalised as a total score of ≥700.
Exclusion NEW:
- Use or having used Doxycyclin in the past 6 months;

CFS patients, additional
-History of Q fever;
-Vaccinated for Q fever.

Healthy volunteers, additional
-History of Q fever;
-Vaccinated for Q fever

Primary outcome NEW:
The primary objective of this study is to evaluate whether there is an increased binding potential of the TSPO ligand [11C]PK11195, which is a marker for microglia activation in neuroinflammation, using PET in patients with chronic fatigue syndrome compared to Q-fever fatigue syndrome and healthy age- and sexe-matched controls.
- RECORD13-jan-2016 - 25-nov-2016


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