Octreotide PET/CT scan 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

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002160-14-NL

Enrollment

Unknown

Registered

2016-10-25

Start date

2016-11-22

Completion date

Unknown

Last updated

2016-11-28

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

Conditions

Sarcoidosis.

Interventions

Product Name: Gallium-68-DOTA-N-Octreotide Product Code: Ga-68-DOTA-NOC Pharmaceutical Form: Injection INN or Proposed INN: Ga-68-DOTA-NOC CAS Number: 1040397-47-4 Other descriptive name: DOTANOC Conc

Eligibility

Sex/Gender

All

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 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

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
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). ;Primary end point(s): • 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. ;Timepoint(s) of evaluation of this end point: Directly; it involves a PET/CT diagnostic intervention.	—

Measure

Time frame

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). ;Primary end point(s): • 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. ;Timepoint(s) of evaluation of this end point: Directly; it involves a PET/CT diagnostic intervention.

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Secondary

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

Countries

Netherlands

Contacts

Public ContactRoeland Vis

St. Antonius Hospital

r.vis@antoniusziekenhuis.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026