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IASOdopa®

6-[18F] Fluoro-L-3,4-dihydroxyphenylalanine

Therapeutic indications

IASOdopa is a diagnostic reagent for the positron emission tomography (PET) and is administered prior to such an examination.

The radioactive agent of IASOdopa (for displaying the dopamine metabolism) is recorded by the PET and displayed as an image.

Neurology

PET with IASOdopa is indicated for the detection of the function loss of dopamine neurons in the striatum. It can be used to diagnose Parkinson’s disease and to differentiate between an essential tremor and the Parkinson syndrome.

Oncology

Amongst other procedures, IASOdopa is indicated for imaging PET procedures within the framework of oncological diagnostics for examining the function and diseases, aiming at displaying an increased intracellular transport as well as the decarboxylation of the amino acid dihydroxyphenylalanine in specific organs and tissues.

The following indicators were in particular documented:

Diagnosis

  • Diagnosis and localisation of insulinomas in the case of hyperinsulinism in babies and children
  • Diagnosis and localisation of glomus tumours in patients with a gene mutation succinate dehydrogenase D Variant
  • Localisation of pheochromocytomas and paragangliomas with negative [123I]-MIBG scintigraphy

Determination of the tumour stage

  • Pheochromocytomas and paragangliomas 

Detection in cases of serious grounds for recurrences

  • Primary brain tumours
  • Pheochromocytomas and paragangliomas with negative [123I]-MIBG scintigraphy
  • Medullary thyroid cancer with increased calcitonin serum concentration
  • Well differentiated carcinomas of the digestive tract  
  • Further endocrine carcinomas of the digestive tract with negative somatostatin receptor scintigraphy

CLINICAL PARTICULARS

Approvals

Country Product Approval number Date of reg. PDF PDF
France IASOdopa 578 256-2 (15mL) 16.11.2006 SPC PIL
France IASOdopa 566 897-8 (25mL) 16.11.2006 SPC PIL
Germany IASOdopa 69747.00.00 04.08.2007 SPC PIL
Austria IASOdopa 4-00032 29.11.2007 SPC PIL
Italy Fluorodopa IASON 038449029 (15mL) 12.09.2013 SPC PIL
Italy Fluorodopa IASON 038449017 (25mL) 12.09.2013 SPC PIL
english IASOdopa   01.08.2007 SPC PIL
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