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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42936

Enrollment

Registered

2016-10-20

Start date

2017-01-19

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pulmonary inflammation Sarcoidose

Interventions

Disease Activity

PET/CT

Sarcoidosis

Somatostatin

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

Measure	Time frame
Secondary parameter: * Correlation between clinical response to immunosuppressive therapy and quantitative uptake measures (myocardial SUVmax and SUVmean for 68Ga-DOTA-NOC).	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)