Octreotide PET/CT scan for the imaging of disease activity in neurologic and cardiac sarcoidosis.

Phase 1

Conditions: Sarcoidosis.
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2016-002160-14-NL

Lead Sponsor: St. Antonius Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •The main objective is to evaluate the role of 68Ga-DOTA-NOC PET/CT in the imaging of disease activity in suspected neurological and cardiac sarcoidosis. ;Secondary Objective: •To assess the correlation between clinical response to immunosuppressive therapy and quantitative uptake measures (myocardial SUVmax and SUVmean for 68Ga-DOTA-NOC).<br>;Primary end point(s): •68Ga-DOTA-NOC uptake (SUVmax and SUVmean) in target tissue (myocard and CNS) of sarcoidosis patients. <br><br>•Sensitivity and specificity of 68Ga-DOTA-NOC PET/CT to determine sarcoidosis activity in neurological and cardiac sarcoidosis analysis. <br>;Timepoint(s) of evaluation of this end point: Directly; it involves a PET/CT diagnostic intervention.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Correlation between clinical response to immunosuppressive therapy and quantitative uptake measures (myocardial SUVmax and SUVmean for 68Ga-DOTA-NOC).<br><br>;Timepoint(s) of evaluation of this end point: Directly; it involves a PET/CT diagnostic intervention.