68Ga-DOTA-NOC PET/CT for the imaging of disease activity in neurologic and cardiac sarcoidosis.

Completed

Conditions: pulmonary inflammation
Sarcoidose
10038716

Registration Number: NL-OMON42936

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

* Men and women > 18 years
* Suspected cardiac sarcoidosis: patients with histologically proven extracardiac sarcoidosis, presenting with either an abnormal ECG, abnormal echocardiogram or symptoms of palpitations/pre-syncope or syncope
* Suspected neurosarcoidosis; patients presenting with symptoms suggestive of central nervous system involvement or with abnormalities during neurologic examination

Exclusion Criteria

* Pregnancy or nursing
* Mental health problems interfering with participation
* Treatment with systemic corticosteroids or other immunosuppressive drugs in the year prior to screening
* History of ischemic heart disease
* Any type of myocardial disease
* Uncontrolled diabetes mellitus

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary parameters:<br /><br><br /><br>* 68Ga-DOTA-NOC uptake (SUVmax and SUVmean) in target tissue (myocard and CNS)<br /><br>of sarcoidosis patients.<br /><br><br /><br>* Sensitivity and specificity of 68Ga-DOTA-NOC PET/CT to determine sarcoidosis<br /><br>activity in neurological and cardiac sarcoidosis analysis.<br /><br><br /><br>Sensitivity and specificity of 68Ga-DOTA-NOC PET/CT will be determined as<br /><br>compared with the diagnostic criteria for definite or probable<br /><br>neurosarcoidosis and a histological* or clinical diagnosis of cardiac<br /><br>sarcoidosis. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameter:<br /><br><br /><br>* Correlation between clinical response to immunosuppressive therapy and<br /><br>quantitative uptake measures (myocardial SUVmax and SUVmean for 68Ga-DOTA-NOC).</p><br>